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U.S. Department of Health and Human Services

Product Classification

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Device gown, patient
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeFYB
Submission Type 510(k)
Regulation Number 878.4040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
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