Device Classification Name |
Forceps, Biopsy, Non-Electric
|
510(k) Number |
K971315 |
Device Name |
AUXILIARY INSTRUMENTS FOR URS |
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 | 876.1075
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/09/1997 |
Decision Date | 09/15/1997 |
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
|
Recalls |
CDRH Recalls
|
|
|