The following data is part of a premarket notification filed by Medical Manufacturers, Inc. with the FDA for Thermo-pack.
| Device ID | K890924 |
| 510k Number | K890924 |
| Device Name: | THERMO-PACK |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | MEDICAL MANUFACTURERS, INC. 750 W. BELLEVIEW AVE. #301 Englewood, CO 80110 |
| Contact | Scott Nichols |
| Correspondent | Scott Nichols MEDICAL MANUFACTURERS, INC. 750 W. BELLEVIEW AVE. #301 Englewood, CO 80110 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-24 |
| Decision Date | 1989-03-14 |