The following data is part of a premarket notification filed by Pcca, Inc. with the FDA for Mucolock Oral Gel.
| Device ID | K203091 |
| 510k Number | K203091 |
| Device Name: | MucoLock Oral Gel |
| Classification | Oral Wound Dressing |
| Applicant | PCCA, Inc. 9901 S. Wilcrest Drive Houston, TX 77099 |
| Contact | Gus Bassani |
| Correspondent | Gus Bassani PCCA, Inc. 9901 S. Wilcrest Drive Houston, TX 77099 |
| Product Code | OLR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-13 |
| Decision Date | 2021-02-12 |