U-CLIP UNI-FIRE, MODEL M65
FDA 510(k) clearance K081082 · decided 2008-05-07
Clearance details
- K-number
- K081082
- Device name
- U-CLIP UNI-FIRE, MODEL M65
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-16
- Decision date
- 2008-05-07
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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