Device Classification Name |
Speculum, Vaginal, Nonmetal, Fiberoptic
|
510(k) Number |
K897100 |
Device Name |
CENTURION VAGINAL SPECULUM |
Applicant |
TRI-STATE HOSPITAL SUPPLY CORP. |
301 CATRELL DR. |
P.O. BOX 170 |
HOWELL,
MI
48843
|
|
Applicant Contact |
GEORGE J PLUTA |
Correspondent |
TRI-STATE HOSPITAL SUPPLY CORP. |
301 CATRELL DR. |
P.O. BOX 170 |
HOWELL,
MI
48843
|
|
Correspondent Contact |
GEORGE J PLUTA |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 12/21/1989 |
Decision Date | 03/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|