HYALO GYN
Lubricant, Personal
FIDIA FARMACEUTICI SPA
The following data is part of a premarket notification filed by Fidia Farmaceutici Spa with the FDA for Hyalo Gyn.
Pre-market Notification Details
| Device ID | K094039 |
| 510k Number | K094039 |
| Device Name: | HYALO GYN |
| Classification | Lubricant, Personal |
| Applicant | FIDIA FARMACEUTICI SPA VIA PONTE DELLA FABBRICA 3/A Abano Terme, Padua (pd), IT 35031 |
| Contact | Giusi Locastro |
| Correspondent | Giusi Locastro FIDIA FARMACEUTICI SPA VIA PONTE DELLA FABBRICA 3/A Abano Terme, Padua (pd), IT 35031 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-30 |
| Decision Date | 2010-05-07 |
| Summary: | summary |
Trademark Results [HYALO GYN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYALO GYN 77121020 3610835 Live/Registered |
Fidia Farmaceutici S.p.a. 2007-03-02 |
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