The following data is part of a premarket notification filed by Omikron Scientific, Ltd. with the FDA for Omiband.
| Device ID | K904445 |
| 510k Number | K904445 |
| Device Name: | OMIBAND |
| Classification | Tape And Bandage, Adhesive |
| Applicant | OMIKRON SCIENTIFIC, LTD. P.O. BOX 2012, KIRYAT WEIZMANN Rehovot-76120, IL |
| Contact | Marc Coles |
| Correspondent | Marc Coles OMIKRON SCIENTIFIC, LTD. P.O. BOX 2012, KIRYAT WEIZMANN Rehovot-76120, IL |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-28 |
| Decision Date | 1991-03-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OMIBAND 74052530 not registered Dead/Abandoned |
Biodan Medical Systems Ltd. 1990-04-24 |