Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K020954 |
Device Name |
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY |
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 | 04/24/2002 |
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
|
|
|