The following data is part of a premarket notification filed by Nice-pak Products, Inc. with the FDA for Ice-pak, Pdi.
| Device ID | K780279 |
| 510k Number | K780279 |
| Device Name: | ICE-PAK, PDI |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | NICE-PAK PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-21 |
| Decision Date | 1978-04-10 |