Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K914201 |
Device Name |
LM- LAP 10 HIGH FLOW INSUFFLATOR |
Applicant |
LEISEGANG MEDICAL, INC. |
6401 CONGRESS AVE. |
BOCA RATON,
FL
33487 -2883
|
|
Applicant Contact |
DOUGLAS KWART |
Correspondent |
LEISEGANG MEDICAL, INC. |
6401 CONGRESS AVE. |
BOCA RATON,
FL
33487 -2883
|
|
Correspondent Contact |
DOUGLAS KWART |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 09/19/1991 |
Decision Date | 01/09/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|