Device Classification Name |
Catheter, Assisted Reproduction
|
510(k) Number |
K990349 |
Device Name |
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST |
Applicant |
COOPERSURGICAL, INC. |
15 FOREST PKWY. |
SHELTON,
CT
06484
|
|
Applicant Contact |
DEBRA A PARKER |
Correspondent |
COOPERSURGICAL, INC. |
15 FOREST PKWY. |
SHELTON,
CT
06484
|
|
Correspondent Contact |
DEBRA A PARKER |
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 02/05/1999 |
Decision Date | 07/26/1999 |
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
|
|
|