The following data is part of a premarket notification filed by Pollak (intl.), Ltd. with the FDA for Pedicat*.
| Device ID | K810049 |
| 510k Number | K810049 |
| Device Name: | PEDICAT* |
| Classification | Lubricant, Patient |
| Applicant | POLLAK (INTL.), LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-04-21 |