SORBOTHANE
FDA 510(k) clearance K810228 · decided 1981-02-10
Clearance details
- K-number
- K810228
- Device name
- SORBOTHANE
- Applicant
- Hamilton Kent
- Decision
- Substantially Equivalent
- Date received
- 1981-01-27
- Decision date
- 1981-02-10
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KNP
- 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 |
|---|---|---|
| IPOS ANTI-ADDUCTUS SHOE (K831690) | Ipos Luneburg | 1983-06-24 |
| SORBOTHANE VISCO INNER SOLE PAD (K831552) | Fred Sammons, Inc. | 1983-06-08 |
| SLIP-ON SANDALS FOR MEASURING SHORTNESS (K823654) | Fred Sammons, Inc. | 1983-01-21 |
| ROTATION BOOT (K823665) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| PLASTAZOTE SHOE (K801743) | Alimed, Inc. | 1980-08-07 |
| DRUSHOE (K790326) | J.E. Hanger & Co. , Ltd. | 1979-02-26 |
Recalls involving this device
No recalls on record reference this clearance.