Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K921086 |
Device Name |
WOM LAPAROFLATOR ELECTRONIC |
Applicant |
W.O.M. GMBH |
PASCALSTRABE 11 |
BERLIN,
DE
D-10587
|
|
Applicant Contact |
OWEN B LAMB |
Correspondent |
W.O.M. GMBH |
PASCALSTRABE 11 |
BERLIN,
DE
D-10587
|
|
Correspondent Contact |
OWEN B LAMB |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/06/1992 |
Decision Date | 04/07/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|