The following data is part of a premarket notification filed by Selomas, Inc. with the FDA for Selopor.
| Device ID | K821258 |
| 510k Number | K821258 |
| Device Name: | SELOPOR |
| Classification | Dressing, Wound, Drug |
| Applicant | SELOMAS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-30 |
| Decision Date | 1982-08-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SELOPOR 73426265 1412934 Dead/Cancelled |
LOHMANN GMBH & CO. KG. 1983-05-12 |