Device Classification Name |
dilator, vaginal
|
510(k) Number |
K003380 |
Device Name |
BIOTEQUE VAGINAL DILATOR |
Applicant |
BIOTEQUE AMERICA, INC. |
340 EAST MAPLE AVE., #204-C |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
DENIS DORSEY |
Correspondent |
BIOTEQUE AMERICA, INC. |
340 EAST MAPLE AVE., #204-C |
LANGHORNE,
PA
19047
|
|
Correspondent Contact |
DENIS DORSEY |
Regulation Number | 884.3900
|
Classification Product Code |
|
Date Received | 10/31/2000 |
Decision Date | 01/29/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|