Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K921722 |
Device Name |
BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA |
Applicant |
BARD REPRODUCTIVE SYSTEMS |
200 AMES POND DR. |
TEWKSBURY,
MA
01876
|
|
Applicant Contact |
MATTHEW NOWLAND |
Correspondent |
BARD REPRODUCTIVE SYSTEMS |
200 AMES POND DR. |
TEWKSBURY,
MA
01876
|
|
Correspondent Contact |
MATTHEW NOWLAND |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 04/09/1992 |
Decision Date | 05/02/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|