Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K031891 |
Device Name |
VIRTUOSAPH |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Applicant Contact |
KIM AVES |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
HEINZ JOERG STENEBERG |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/13/2003 |
Decision Date | 07/29/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|