REJUVENESS
FDA 510(k) clearance K974380 · decided 1998-04-03
Clearance details
- K-number
- K974380
- Device name
- REJUVENESS
- Applicant
- Rejuveness Pharamceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-21
- Decision date
- 1998-04-03
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- MDA
- Device class
- 1
- Regulation number
- 878.4025
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ballston Spa, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.