The following data is part of a premarket notification filed by Fidia Farmaceutici S.p.a with the FDA for Hyalogyn Vaginal Moisturizing Suppositories.
| Device ID | K191052 |
| 510k Number | K191052 |
| Device Name: | HyaloGYN Vaginal Moisturizing Suppositories |
| Classification | Lubricant, Personal |
| Applicant | Fidia Farmaceutici S.p.A Via Ponte Della Fabbrica 3/A Abano Terme, IT 35031 |
| Contact | Giuseppina Lo Castro |
| Correspondent | Vivian Kelly Fidia Pharma USA, Inc. 100 Campus Drive Florham Park, NJ 07932 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-19 |
| Decision Date | 2020-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M713100004050 | K191052 | 000 |
| M713100004040 | K191052 | 000 |
| 00368093000049 | K191052 | 000 |
| 00368093000032 | K191052 | 000 |