The following data is part of a premarket notification filed by U.s. Export Marketing Group, Inc. with the FDA for Warm-ee Heat Pack.
| Device ID | K791684 |
| 510k Number | K791684 |
| Device Name: | WARM-EE HEAT PACK |
| Classification | Pack, Hot Or Cold, Reusable |
| Applicant | U.S. EXPORT MARKETING GROUP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IME |
| CFR Regulation Number | 890.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-28 |
| Decision Date | 1979-10-30 |