Device Classification Name |
Cannula, Intrauterine Insemination
|
510(k) Number |
K964848 |
Device Name |
WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM |
Applicant |
MARLOW SURGICAL TECHNOLOGIES, INC. |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Applicant Contact |
ARTHUR S GODDARD |
Correspondent |
MARLOW SURGICAL TECHNOLOGIES, INC. |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Correspondent Contact |
ARTHUR S GODDARD |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 12/03/1996 |
Decision Date | 01/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|