Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K000337 |
Device Name |
MTP DISPOSABLE TROCAR VALVES |
Applicant |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230
|
|
Applicant Contact |
KEVIN KENNAN |
Correspondent |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230
|
|
Correspondent Contact |
KEVIN KENNAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/03/2000 |
Decision Date | 04/12/2000 |
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
|