Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K071127 |
Device Name |
FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM |
Applicant |
VISION-SCIENCES, INC. |
5 WHITCOMB AVE. |
AYER,
MA
01432
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
VISION-SCIENCES, INC. |
5 WHITCOMB AVE. |
AYER,
MA
01432
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 04/23/2007 |
Decision Date | 11/16/2007 |
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
|
|
|