Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K020951 |
Device Name |
H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 |
Applicant |
ACKRAD LABORATORIES |
70 JACKSON DR. |
CRANFORD,
NJ
07016
|
|
Applicant Contact |
RICHARD HETTENBACH |
Correspondent |
ACKRAD LABORATORIES |
70 JACKSON DR. |
CRANFORD,
NJ
07016
|
|
Correspondent Contact |
RICHARD HETTENBACH |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 03/25/2002 |
Decision Date | 04/16/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|