Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K141515 |
Device Name |
AED HYSTEROSCOPE AND ACCESSORIES |
Applicant |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
22134 SHERMAN WAY |
CANOGA PARK,
CA
91303
|
|
Applicant Contact |
GAYLE BUTLER |
Correspondent |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
22134 SHERMAN WAY |
CANOGA PARK,
CA
91303
|
|
Correspondent Contact |
GAYLE BUTLER |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 06/09/2014 |
Decision Date | 01/07/2015 |
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
|
|
|