SOFT CATCHER'S MITT
FDA 510(k) clearance K823656 · decided 1983-01-21
Clearance details
- K-number
- K823656
- Device name
- SOFT CATCHER'S MITT
- Applicant
- Fred Sammons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-06
- Decision date
- 1983-01-21
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- ILT
- Device class
- 1
- Regulation number
- 890.5050
- 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 |
|---|---|---|
| CARD HOLDER FOR QUADS (K823657) | Fred Sammons, Inc. | 1983-01-21 |
| HOLDER, CARD, QUAD-QUIP (K781199) | Fred Sammons, Inc. | 1978-07-31 |
| BREATH CONTROL GAME (K761116) | Fred Sammons, Inc. | 1976-12-02 |
| HOLDER, PENCIL & CRAYON, WITH STAND (K760291) | Fred Sammons, Inc. | 1976-09-08 |
| CARDS, GIANT FACE PLAYING BK-9419 (K760306) | Fred Sammons, Inc. | 1976-09-08 |
| VIEWER, RECLINING, BK-4089 (K760288) | Fred Sammons, Inc. | 1976-09-08 |
Recalls involving this device
No recalls on record reference this clearance.