The following data is part of a premarket notification filed by Omec Medical, Inc. with the FDA for O-mec 690 Series Laparoscopes.
| Device ID | K201151 |
| 510k Number | K201151 |
| Device Name: | O-Mec 690 Series Laparoscopes |
| Classification | Proctoscope |
| Applicant | OMEC Medical, Inc. 2370 Qume Drive, Suite A San Jose, CA 95131 |
| Contact | Claire Nippress |
| Correspondent | Yolanda Smith Smith Associates|56345 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | GCF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-29 |
| Decision Date | 2020-06-22 |