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U.S. Department of Health and Human Services

Product Classification
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Device protector, wound, plastic
Regulation Description Nonresorbable gauze/sponge for external use.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeEYF
Premarket Review Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4014
Device Class 1
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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