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U.S. Department of Health and Human Services

Product Classification
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Device endoscopic storage cover
Regulation Description Endoscope and accessories.
Definition To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.
Physical State cover or sheath
Technical Method Placed over endoscope or parts of the endoscope.
Target Area delicate parts of endoscope
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeOCU
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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