The following data is part of a premarket notification filed by Fidia Farmaceutici Spa with the FDA for Hyalogyn Vaginal Hydrating Gel.
| Device ID | K150883 |
| 510k Number | K150883 |
| Device Name: | HyaloGYN Vaginal Hydrating Gel |
| Classification | Lubricant, Personal |
| Applicant | FIDIA FARMACEUTICI SPA VIA PONTE DELLA FABBRICA 3/A Abano Terme, IT 35031 |
| Contact | Dr. Giuseppina Lo Castro |
| Correspondent | Vivian Kelly Fidia Pharma USA Inc Morris Corporate Center 1, Building C, 300 Interpace Parkway Parsippany, NJ 07054 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-02 |
| Decision Date | 2015-09-01 |
| Summary: | summary |