TEMP STERNUM SAW
FDA 510(k) clearance K801914 · decided 1980-10-23
Clearance details
- K-number
- K801914
- Device name
- TEMP STERNUM SAW
- Applicant
- Temp Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-11
- Decision date
- 1980-10-23
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- DWI
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| STRYKER ECLIPSE WARMING STRETCHER (K912237) | Stryker Medical | 1991-07-30 |
Recalls involving this device
No recalls on record reference this clearance.