EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER— 510(k) K111535
Substantially EquivalentExact Medical Manufacturing, Inc.
FDA 510(k) clearance K111535 for EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER, Substantially Equivalent on 2011-08-26. 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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- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
More clearances from Exact Medical Manufacturing, Inc.
view all- K121919 — SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
- K120045 — EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
- 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.