Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K033113 |
Device Name |
UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 |
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 | 884.1690
|
Classification Product Code |
|
Date Received | 09/30/2003 |
Decision Date | 12/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|