OVERHEAD ARM SLINGS
FDA 510(k) clearance K823811 · decided 1983-01-14
Clearance details
- K-number
- K823811
- Device name
- OVERHEAD ARM SLINGS
- 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
- ILE
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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 |
|---|---|---|
| OB HELP ARM (K830842) | Lic-Orthion | 1983-04-05 |
| OB HELP ARM (K823152) | Orthion Corp. | 1982-11-05 |
Recalls involving this device
No recalls on record reference this clearance.