EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL— 510(k) K101593
Substantially EquivalentExact Medical Manufacturing, Inc.
FDA 510(k) clearance K101593 for EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL, Substantially Equivalent on 2010-09-03. 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.