Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K921756 |
Device Name |
ELECTRONIC INSUFFLATOR MODEL 2054.61 |
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 | 884.1730
|
Classification Product Code |
|
Date Received | 04/13/1992 |
Decision Date | 03/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|