The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ice Pack, Reusable Flexible.
| Device ID | K790009 |
| 510k Number | K790009 |
| Device Name: | ICE PACK, REUSABLE FLEXIBLE |
| Classification | Pack, Hot Or Cold, Reusable |
| Applicant | ACKRAD LABORATORIES 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 | 1979-01-02 |
| Decision Date | 1979-01-22 |