The following data is part of a premarket notification filed by Lazarus Medical, Inc. with the FDA for Cannula Introduction Set.
| Device ID | K910015 |
| 510k Number | K910015 |
| Device Name: | CANNULA INTRODUCTION SET |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | LAZARUS MEDICAL, INC. 324-10TH AVE. SUITE 260 Salt Lake City, UT 84103 |
| Contact | Harrison M Lazarus |
| Correspondent | Harrison M Lazarus LAZARUS MEDICAL, INC. 324-10TH AVE. SUITE 260 Salt Lake City, UT 84103 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-02 |
| Decision Date | 1991-04-02 |