TRANSPOSAL ULTRA SYSTEMS
FDA 510(k) clearance K081047 · decided 2008-04-29
Clearance details
- K-number
- K081047
- Device name
- TRANSPOSAL ULTRA SYSTEMS
- Applicant
- Dornoch Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-14
- Decision date
- 2008-04-29
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Riverside, MO, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.