The following data is part of a premarket notification filed by Kedumin Kits, Ltd. with the FDA for Safebris Sterile Circumcision Kit.
| Device ID | K902119 |
| 510k Number | K902119 |
| Device Name: | SAFEBRIS STERILE CIRCUMCISION KIT |
| Classification | Shield, Circumcision |
| Applicant | KEDUMIN KITS, LTD. P.O. BOX 2273 Rehovot, Israel, IL |
| Contact | Orbach, Ph.d. |
| Correspondent | Orbach, Ph.d. KEDUMIN KITS, LTD. P.O. BOX 2273 Rehovot, Israel, IL |
| Product Code | FHJ |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-09 |
| Decision Date | 1990-11-05 |