COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS— 510(k) K041540
Substantially EquivalentStandard Textile Co., Inc.
FDA 510(k) clearance K041540 for COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS, Substantially Equivalent on 2005-05-05. Applicant: Standard Textile Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Standard Textile Co., 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
- Cincinnati, OH, US
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More clearances from Standard Textile Co., Inc.
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