TECNOL O.R. TOURNIQUET COVER
FDA 510(k) clearance K802850 · decided 1981-01-13
Clearance details
- K-number
- K802850
- Device name
- TECNOL O.R. TOURNIQUET COVER
- Applicant
- Tecnol New Jersey Wound Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-12
- Decision date
- 1981-01-13
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- EYR
- Device class
- 1
- Regulation number
- 878.5900
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hammonton, NJ, 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 |
|---|---|---|
| KEITHLEY CLAMP (K792256) | Keithley Development Co. | 1979-12-06 |
Recalls involving this device
No recalls on record reference this clearance.