The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Infant Heel Warmer (model 24401) And Warmgel Infant Heel Warmer (model 20418).
| Device ID | K151845 |
| 510k Number | K151845 |
| Device Name: | Infant Heel Warmer (Model 24401) And WarmGel Infant Heel Warmer (Model 20418) |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| Applicant | COOPERSURGICAL, INC. 95 CORPORATE DR. Trumbull, CT 06611 |
| Contact | Roaida Johnson |
| Correspondent | Roaida Johnson COOPERSURGICAL, INC. 95 CORPORATE DR. Trumbull, CT 06611 |
| Product Code | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-07 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937025716 | K151845 | 000 |
| 30888937025690 | K151845 | 000 |