Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K021272 |
Device Name |
SIB CATHETER, MODEL 61-7005 |
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 | 04/22/2002 |
Decision Date | 05/21/2002 |
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
|
|
|