Device Classification Name |
culdoscope (and accessories)
|
510(k) Number |
K992655 |
Device Name |
FERTILOSCOPY KIT FH 1.29/FTO 1.40 |
Applicant |
SOPRANE S.A. |
555 THIRTEENTH ST., N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
SOPRANE S.A. |
555 THIRTEENTH ST., N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Regulation Number | 884.1640
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/09/1999 |
Decision Date | 03/13/2000 |
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
|
|
|