RESTING PAN SPLINTS
FDA 510(k) clearance K772410 · decided 1978-01-05
Clearance details
- K-number
- K772410
- Device name
- RESTING PAN SPLINTS
- Applicant
- Fred Sammons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-27
- Decision date
- 1978-01-05
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- ILH
- 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 |
|---|---|---|
| SPLINT WOOD (K832144) | Vermont Wood Industries, Inc. | 1983-08-01 |
| SPLINTS (K831548) | Fred Sammons, Inc. | 1983-06-27 |
| FINGER EXTENSION SPLINT (K823647) | Fred Sammons, Inc. | 1983-01-21 |
| FINGER FLEXION SPLINT (K823644) | Fred Sammons, Inc. | 1983-01-21 |
| UNIVERSAL WRIST SPLINT & FOREARM SPLINT (K823666) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| WRIST SUPPORT (K823601) | Fred Sammons, Inc. | 1982-12-22 |
| STAX FINGER SPLINTS (K823393) | Orthopedic Systems, Inc. | 1982-12-03 |
| WRIST SPLING & FOREARM SPLINT (K823165) | Warm & Form, Orthopedic Materials | 1982-11-16 |
| TOTAL FINGER FLEXION SPLINT (K822651) | Alimed, Inc. | 1982-09-17 |
| WIRE-FOAM MP FLEXION SPRING (K821637) | Fred Sammons, Inc. | 1982-06-11 |
| SOFT ULNAR DEVIATION SPLINTS (K821635) | Fred Sammons, Inc. | 1982-06-11 |
| STAX FINGER SPLINT (K820826) | Conco Medical Co. | 1982-04-08 |
Recalls involving this device
No recalls on record reference this clearance.