The following data is part of a premarket notification filed by Pollak (intl.), Ltd. with the FDA for Finger Painguard Cat.#193-194.
| Device ID | K802015 |
| 510k Number | K802015 |
| Device Name: | FINGER PAINGUARD CAT.#193-194 |
| Classification | Bandage, Elastic |
| Applicant | POLLAK (INTL.), LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQM |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-20 |
| Decision Date | 1980-09-09 |