MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE— 510(k) K012240
Substantially EquivalentMercan AB
FDA 510(k) clearance K012240 for MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE, Substantially Equivalent on 2001-10-15. Applicant: Mercan AB. Device class: 2.
Clearance details
- Applicant
- Mercan AB
- 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
- Austin, TX, US
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More clearances from Mercan AB
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