The following data is part of a premarket notification filed by Eimark Labs, Inc. with the FDA for Benderev Protect-a-pass Needle.
| Device ID | K921228 |
| 510k Number | K921228 |
| Device Name: | BENDEREV PROTECT-A-PASS NEEDLE |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | EIMARK LABS, INC. 26732 CROWN VALLEY PKWY. SUITE 501 Mission Viejo, CA 92691 |
| Contact | Neil Naves |
| Correspondent | Neil Naves EIMARK LABS, INC. 26732 CROWN VALLEY PKWY. SUITE 501 Mission Viejo, CA 92691 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-13 |
| Decision Date | 1992-09-14 |