Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K910015 |
Device Name |
CANNULA INTRODUCTION SET |
Applicant |
LAZARUS MEDICAL, INC. |
324-10TH AVE. |
SUITE 260 |
SALT LAKE CITY,
UT
84103
|
|
Applicant Contact |
HARRISON M LAZARUS |
Correspondent |
LAZARUS MEDICAL, INC. |
324-10TH AVE. |
SUITE 260 |
SALT LAKE CITY,
UT
84103
|
|
Correspondent Contact |
HARRISON M LAZARUS |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 01/02/1991 |
Decision Date | 04/02/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|