Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K014158 |
Device Name |
ENDOSCOPIC CAMERA TC804/C4 |
Applicant |
WORLD OF MEDICINE LEMKE GMBH |
91 TROWBRIDGE ST. |
CAMBRIDGE,
MA
02138
|
|
Applicant Contact |
SUSANNE RAAB |
Correspondent |
WORLD OF MEDICINE LEMKE GMBH |
91 TROWBRIDGE ST. |
CAMBRIDGE,
MA
02138
|
|
Correspondent Contact |
SUSANNE RAAB |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/19/2001 |
Decision Date | 03/14/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|