The following data is part of a premarket notification filed by Duro-med Ind., Inc. with the FDA for Moist Heat Pack.
| Device ID | K803177 |
| 510k Number | K803177 |
| Device Name: | MOIST HEAT PACK |
| Classification | Pack, Heat, Moist |
| Applicant | DURO-MED IND., 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 | 1980-12-16 |
| Decision Date | 1980-12-31 |