LIMB COVER
FDA 510(k) clearance K780905 · decided 1978-08-14
Clearance details
- K-number
- K780905
- Device name
- LIMB COVER
- Applicant
- Hydro-Med Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-02
- Decision date
- 1978-08-14
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- IPM
- Device class
- 1
- Regulation number
- 890.3025
- 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 |
|---|---|---|
| ELASTO-GEL CAST & SPLINT PADS (K872488) | Southwest Technologies, Inc. | 1987-09-21 |
| COVER LIMB (K823399) | Orthopedic Systems, Inc. | 1982-11-29 |
| COVER, LIMB (K801627) | The Owenby Co. | 1980-07-28 |
| HEAVY FOAM HEEL & ELBOW PROTECTORS (K770223) | Robert R. Moore | 1977-02-23 |
| FOAM SLIPPERS (K761114) | Fred Sammons, Inc. | 1976-12-02 |
Recalls involving this device
No recalls on record reference this clearance.