The following data is part of a premarket notification filed by Farma-derma S.r.l. with the FDA for Repagyn Vaginal Suppositories.
| Device ID | K153372 |
| 510k Number | K153372 |
| Device Name: | Repagyn Vaginal Suppositories |
| Classification | Lubricant, Personal |
| Applicant | FARMA-DERMA S.R.L. VIA DEI BERSAGLIERI,10 Sala Bolognese, IT 40010 |
| Contact | Mara Calzolari |
| Correspondent | Mara Calzolari FARMA-DERMA S.R.L. VIA DEI BERSAGLIERI,10 Sala Bolognese, IT 40010 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08032595871071 | K153372 | 000 |
| 08032595871064 | K153372 | 000 |