The following data is part of a premarket notification filed by Polichem S.a. with the FDA for Me Again(r) Long Lasting Vaginal Moisturizer, Vh Essentials (r) Long Lasting Vaginal Moisturizer.
| Device ID | K112217 |
| 510k Number | K112217 |
| Device Name: | ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER |
| Classification | Lubricant, Personal |
| Applicant | POLICHEM S.A. 1 PHARMACAL WAY Jackson, WI 53037 |
| Contact | John Nygaard |
| Correspondent | John Nygaard POLICHEM S.A. 1 PHARMACAL WAY Jackson, WI 53037 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-02 |
| Decision Date | 2012-10-16 |
| Summary: | summary |