SAV-A-LIMB
FDA 510(k) clearance K833872 · decided 1984-02-04
Clearance details
- K-number
- K833872
- Device name
- SAV-A-LIMB
- Applicant
- Sil-Med Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-08
- Decision date
- 1984-02-04
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KYR
- Device class
- 1
- Regulation number
- 880.6050
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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 |
|---|---|---|
| VINYL ICE BAG (K810653) | First Industries, Inc. | 1981-03-27 |
| ICE BAG, VINYL (K780608) | Abco Dealers, Inc. | 1978-06-06 |
| DEVON COOL FACE (K760951) | Devon Industries, Inc. | 1976-12-30 |
Recalls involving this device
No recalls on record reference this clearance.