The following data is part of a premarket notification filed by Selomas, Inc. with the FDA for Selofix.
Device ID | K821257 |
510k Number | K821257 |
Device Name: | SELOFIX |
Classification | Tape And Bandage, Adhesive |
Applicant | SELOMAS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-30 |
Decision Date | 1982-05-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SELOFIX 73425574 not registered Dead/Abandoned |
LOHMANN GMBH & CO. KG 1983-05-12 |