POWERPRO BATTERY SYSTEM
FDA 510(k) clearance K012320 · decided 2001-10-19
Clearance details
- K-number
- K012320
- Device name
- POWERPRO BATTERY SYSTEM
- Applicant
- Linvatec Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-23
- Decision date
- 2001-10-19
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HAB
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SNAP STERNUM SAW (K935517) | Surgiquip, Inc. | 1994-03-10 |
Recalls involving this device
No recalls on record reference this clearance.