MX-7000 MICROXEL— 510(k) K111831
Substantially EquivalentBio-Med USA, Inc.
FDA 510(k) clearance K111831 for MX-7000 MICROXEL, Substantially Equivalent on 2011-12-19. Applicant: Bio-Med USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Med USA, Inc.
- Product code
- Code ONG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paterson, NJ, US
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