MX-7000 MICROXEL
FDA 510(k) clearance K111831 · decided 2011-12-19
Clearance details
- K-number
- K111831
- Device name
- MX-7000 MICROXEL
- Applicant
- Bio-Med USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-28
- Decision date
- 2011-12-19
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- ONG
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Paterson, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.