Device Classification Name |
lubricant, personal
|
510(k) Number |
K150883 |
FOIA Releasable 510(k) |
K150883
|
Device Name |
HyaloGYN Vaginal Hydrating Gel |
Applicant |
FIDIA FARMACEUTICI SPA |
VIA PONTE DELLA FABBRICA 3/A |
ABANO TERME,
IT
35031
|
|
Applicant Contact |
Dr. Giuseppina Lo Castro |
Correspondent |
Fidia Pharma USA Inc |
Morris Corporate Center 1, Building C, 300 Interpace Parkway |
Parsippany,
NJ
07054
|
|
Correspondent Contact |
Vivian Kelly |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/02/2015 |
Decision Date | 09/01/2015 |
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
|
|
|