Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K003417 |
Device Name |
MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET |
Applicant |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. |
VERNON HILLS,
IL
60061
|
|
Applicant Contact |
ROBERT L CASARSA |
Correspondent |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. |
VERNON HILLS,
IL
60061
|
|
Correspondent Contact |
ROBERT L CASARSA |
Regulation Number | 884.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/02/2000 |
Decision Date | 04/04/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|