The following data is part of a premarket notification filed by Pollak (intl.), Ltd. with the FDA for Lap Sponges Cat.#801-850.
| Device ID | K802001 |
| 510k Number | K802001 |
| Device Name: | LAP SPONGES CAT.#801-850 |
| Classification | Drape, Surgical |
| Applicant | POLLAK (INTL.), LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-20 |
| Decision Date | 1980-09-16 |