The following data is part of a premarket notification filed by Sunbeam Corp. with the FDA for Cold Pack #589.
| Device ID | K801776 |
| 510k Number | K801776 |
| Device Name: | COLD PACK #589 |
| Classification | Pack, Hot Or Cold, Reusable |
| Applicant | SUNBEAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IME |
| CFR Regulation Number | 890.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-08-07 |