The following data is part of a premarket notification filed by Omikron Scientific, Ltd. with the FDA for Modified Manufacturing Process For Omiderm(tm).
| Device ID | K874480 |
| 510k Number | K874480 |
| Device Name: | MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) |
| Classification | Dressing, Wound, Drug |
| Applicant | OMIKRON SCIENTIFIC, LTD. KIRYAT WEIZMANN P.O.B. 2012, REHOVOT 76120 Israel, IL |
| Contact | Marc Coles |
| Correspondent | Marc Coles OMIKRON SCIENTIFIC, LTD. KIRYAT WEIZMANN P.O.B. 2012, REHOVOT 76120 Israel, IL |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-02 |
| Decision Date | 1988-02-22 |