INSTANT WARM GEL PACK
FDA 510(k) clearance K912715 · decided 1991-10-02
Clearance details
- K-number
- K912715
- Device name
- INSTANT WARM GEL PACK
- Applicant
- Prism Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-18
- Decision date
- 1991-10-02
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- IMD
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P recall (Z-1298-2015) | CooperSurgical, Inc. | 2015-03-19 |
| Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant H recall (Z-1299-2015) | CooperSurgical, Inc. | 2015-03-19 |
| MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel War recall (Z-1300-2015) | CooperSurgical, Inc. | 2015-03-19 |
| NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Wa recall (Z-1301-2015) | CooperSurgical, Inc. | 2015-03-19 |