EMM EQUIPMENT COVER-POLYTHYLENE— 510(k) K101689
Substantially EquivalentExact Medical Manufacturing, Inc.
FDA 510(k) clearance K101689 for EMM EQUIPMENT COVER-POLYTHYLENE, 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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view all- K121919 — SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
- K120045 — EMM HIGH PERFORMANCE SURGICAL GOWN 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
Recalls naming K101689
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101689.
Data sourced from openFDA. This site is unofficial and independent of the FDA.