EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV— 510(k) K120045
Substantially EquivalentExact Medical Manufacturing, Inc.
FDA 510(k) clearance K120045 for EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV, Substantially Equivalent on 2012-06-12. Applicant: Exact Medical Manufacturing, Inc.. Device class: 2.
Clearance details
- Applicant
- Exact Medical Manufacturing, Inc.
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
Recent devices under product code FYA
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More clearances from Exact Medical Manufacturing, Inc.
view all- K121919 — SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
- K111535 — EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
- K101598 — EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)
- K101688 — EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
- K101689 — EMM EQUIPMENT COVER-POLYTHYLENE
Data sourced from openFDA. This site is unofficial and independent of the FDA.