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U.S. Department of Health and Human Services

Product Classification

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Device cover, barrier, protective
Regulation Description Surgical drape and drape accessories.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeMMP
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 878.4370
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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