SOFTGOOD PRODUCTS AND SPLINTS
FDA 510(k) clearance K803239 · decided 1981-01-09
Clearance details
- K-number
- K803239
- Device name
- SOFTGOOD PRODUCTS AND SPLINTS
- Applicant
- Danek Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-23
- Decision date
- 1981-01-09
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- IPX
- Device class
- 1
- Regulation number
- 890.3490
- 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 |
|---|---|---|
| RIB BELT (UNIVERSAL) (K823662) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| RIB BELT (UNIVERSAL) (K823158) | Warm & Form, Orthopedic Materials | 1982-11-10 |
Recalls involving this device
No recalls on record reference this clearance.