The following data is part of a premarket notification filed by Tru-eze Mfg. Co., Inc. with the FDA for Reusable Moist Heat Pack.
| Device ID | K791653 |
| 510k Number | K791653 |
| Device Name: | REUSABLE MOIST HEAT PACK |
| Classification | Pack, Heat, Moist |
| Applicant | TRU-EZE MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IMA |
| CFR Regulation Number | 890.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-14 |
| Decision Date | 1979-09-07 |