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U.S. Department of Health and Human Services

Product Classification
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Device d and c tray
Definition This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Physical State This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Technical Method This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Target Area This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Review Panel Obstetrics/Gynecology
Product CodePKF
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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