FLAT WRENCH
FDA 510(k) clearance K781451 · decided 1978-09-27
Clearance details
- K-number
- K781451
- Device name
- FLAT WRENCH
- Applicant
- Orthopedic Equipment Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-08-23
- Decision date
- 1978-09-27
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- HXS
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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 |
|---|---|---|
| KLEIN WIRE TIGHTENER/BIONIC WIRE (K833726) | Bionic Instrument Corp. | 1983-12-22 |
Recalls involving this device
No recalls on record reference this clearance.