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 |