The following data is part of a premarket notification filed by Selomas, Inc. with the FDA for Silkafix Adhesive Plaster.
| Device ID | K821490 |
| 510k Number | K821490 |
| Device Name: | SILKAFIX ADHESIVE PLASTER |
| 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 | 1982-05-18 |
| Decision Date | 1982-06-02 |