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U.S. Department of Health and Human Services

Product Classification
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Device tube, tympanostomy, porous polyethylene
Regulation Description Tympanostomy tube.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeLBL
Submission Type 510(k)
Regulation Number 874.3880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification; Final [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080204.pdf] 
Third Party Review Not Third Party Eligible
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