The following data is part of a premarket notification filed by International Biomedical with the FDA for Infant Heel Warmertm; Heel Snuggler®.
| Device ID | K221154 |
| 510k Number | K221154 |
| Device Name: | Infant Heel WarmerTM; Heel Snuggler® |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| Applicant | International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Contact | Amy Pieper |
| Correspondent | Amy Pieper International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Product Code | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-21 |
| Decision Date | 2022-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850018561600 | K221154 | 000 |
| 00850018561594 | K221154 | 000 |