EDCOOL AND EDCOOL JR. INSTANT COLD PACK
FDA 510(k) clearance K871006 · decided 1987-03-25
Clearance details
- K-number
- K871006
- Device name
- EDCOOL AND EDCOOL JR. INSTANT COLD PACK
- Applicant
- Advantage Credit Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-13
- Decision date
- 1987-03-25
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- IMP
- Device class
- 1
- Regulation number
- 890.3920
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Kansas City, MO, 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 |
|---|---|---|
| ULTIMA WHEELCHAIR CUSHION (K890653) | Clark Pillow Co., Inc. | 1989-02-28 |
Recalls involving this device
No recalls on record reference this clearance.