CLAVICAL STRAP
FDA 510(k) clearance K823809 · decided 1983-01-14
Clearance details
- K-number
- K823809
- Device name
- CLAVICAL STRAP
- Applicant
- Danek Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-17
- Decision date
- 1983-01-14
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- IQJ
- Device class
- 1
- Regulation number
- 890.3490
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, 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 |
|---|---|---|
| CLAVICLE SUPPORT (K823661) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| CLAVICLE SUPPORT (K823157) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| RICHARDS CLAVICLE STRAP (K760577) | Richard'S Medical Equip., Inc. | 1976-10-06 |
Recalls involving this device
No recalls on record reference this clearance.