The following data is part of a premarket notification filed by Nice-pak Products, Inc. with the FDA for Iso-care Kit.
| Device ID | K781539 |
| 510k Number | K781539 |
| Device Name: | ISO-CARE KIT |
| Classification | Pad, Eye |
| Applicant | NICE-PAK PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-08 |
| Decision Date | 1978-11-03 |