The following data is part of a premarket notification filed by Pollak (intl.), Ltd. with the FDA for Eye Pads Cat.#581-599.
| Device ID | K801995 |
| 510k Number | K801995 |
| Device Name: | EYE PADS CAT.#581-599 |
| Classification | Pad, Eye |
| Applicant | POLLAK (INTL.), LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-20 |
| Decision Date | 1980-09-09 |