The following data is part of a premarket notification filed by Polichem S.a. with the FDA for Gynomunal.
| Device ID | K143349 |
| 510k Number | K143349 |
| Device Name: | Gynomunal |
| Classification | Lubricant, Personal |
| Applicant | POLICHEM S.A. VIA SENAGO 42D Lugano-pazzallo, CH 6912 |
| Contact | Daria Mari |
| Correspondent | Barry E Sands RQMIS, INC. 29 WATER STREET SUITE 305 Newburyport, MA 01950 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-24 |
| Decision Date | 2015-09-16 |
| Summary: | summary |