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 |