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 |