The following data is part of a premarket notification filed by Omni Therm, Inc. with the FDA for Omni Cold Gel Packs.
| Device ID | K954877 |
| 510k Number | K954877 |
| Device Name: | OMNI COLD GEL PACKS |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | OMNI THERM, INC. 2338 WELDON PKWY. St. Louis, MO 63146 |
| Contact | Matt Walters |
| Correspondent | Matt Walters OMNI THERM, INC. 2338 WELDON PKWY. St. Louis, MO 63146 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-24 |
| Decision Date | 1996-02-13 |