EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004— 510(k) K101688
Substantially EquivalentExact Medical Manufacturing, Inc.
FDA 510(k) clearance K101688 for EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004, Substantially Equivalent on 2010-09-20. Applicant: Exact Medical Manufacturing, Inc.. Device class: 2.
Clearance details
- Applicant
- Exact Medical Manufacturing, Inc.
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
Recent devices under product code KKX
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