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 |