The following data is part of a premarket notification filed by Denovo Products Llc with the FDA for Denovo Teddy Gel Infant Heel Warmer.
| Device ID | K103549 |
| 510k Number | K103549 |
| Device Name: | DENOVO TEDDY GEL INFANT HEEL WARMER |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| Applicant | DENOVO PRODUCTS LLC 17051 Alico Commerce Court Unit 3 Fort Myers, FL 33967 |
| Contact | Dale Walters |
| Correspondent | Dale Walters DENOVO PRODUCTS LLC 17051 Alico Commerce Court Unit 3 Fort Myers, FL 33967 |
| Product Code | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-03 |
| Decision Date | 2011-04-08 |