The following data is part of a premarket notification filed by Thermionics Corp. with the FDA for Hot Or Cold Pack (thermipaq).
| Device ID | K921446 |
| 510k Number | K921446 |
| Device Name: | HOT OR COLD PACK (THERMIPAQ) |
| Classification | Pack, Hot Or Cold, Reusable |
| Applicant | THERMIONICS CORP. 828 S. SECOND ST. Springfield, IL 62704 |
| Contact | Terry L Pancake |
| Correspondent | Terry L Pancake THERMIONICS CORP. 828 S. SECOND ST. Springfield, IL 62704 |
| Product Code | IME |
| CFR Regulation Number | 890.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-27 |
| Decision Date | 1992-07-13 |