ICE BAG, VINYL
FDA 510(k) clearance K780608 · decided 1978-06-06
Clearance details
- K-number
- K780608
- Device name
- ICE BAG, VINYL
- Applicant
- Abco Dealers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-04-10
- Decision date
- 1978-06-06
- Days to decision
- 57 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 |
|---|---|---|
| SAV-A-LIMB (K833872) | Sil-Med Corp. | 1984-02-04 |
| VINYL ICE BAG (K810653) | First Industries, Inc. | 1981-03-27 |
| DEVON COOL FACE (K760951) | Devon Industries, Inc. | 1976-12-30 |
Recalls involving this device
No recalls on record reference this clearance.