Device Classification Name |
speculum, vaginal, nonmetal
|
510(k) Number |
K000444 |
Device Name |
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM |
Applicant |
PRISM ENTERPRISES, INC. |
10 AUBREY COURT |
SAN ANTONIO,
TX
78216
|
|
Applicant Contact |
JUDITH A HARBOUR |
Correspondent |
PRISM ENTERPRISES, INC. |
10 AUBREY COURT |
SAN ANTONIO,
TX
78216
|
|
Correspondent Contact |
JUDITH A HARBOUR |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 02/10/2000 |
Decision Date | 04/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|