Device Classification Name |
Culdoscope (And Accessories)
|
510(k) Number |
K954311 |
Device Name |
KOH COLPOTOMIZER SYSTEM |
Applicant |
COOPERSURGICAL, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
MARY M MCNAMARA |
Correspondent |
COOPERSURGICAL, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
MARY M MCNAMARA |
Regulation Number | 884.1640
|
Classification Product Code |
|
Date Received | 09/15/1995 |
Decision Date | 11/19/1996 |
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
|
|
|