Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K951522 |
Device Name |
WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA |
Applicant |
WOODBINE OPTICAL CORP. |
41 BROOKS DR. |
BRAINTREE,
MA
02184
|
|
Applicant Contact |
ROBERT H SEGERSTEN |
Correspondent |
WOODBINE OPTICAL CORP. |
41 BROOKS DR. |
BRAINTREE,
MA
02184
|
|
Correspondent Contact |
ROBERT H SEGERSTEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/03/1995 |
Decision Date | 06/16/1995 |
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
|