Device Classification Name |
Resectoscope
|
510(k) Number |
K042523 |
Device Name |
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES |
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 | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/17/2004 |
Decision Date | 03/18/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|