The following data is part of a premarket notification filed by Church & Dwight Co., Inc with the FDA for Replens Long-lasting Vaginal Moisturizer.
| Device ID | K203818 |
| 510k Number | K203818 |
| Device Name: | Replens Long-Lasting Vaginal Moisturizer |
| Classification | Lubricant, Personal |
| Applicant | Church & Dwight Co., Inc 500 Charles Ewing Blvd. Ewing, NJ 08628 |
| Contact | Supreet Sahota-bhatti |
| Correspondent | Supreet Sahota-bhatti Church & Dwight Co., Inc 500 Charles Ewing Blvd. Ewing, NJ 08628 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-29 |
| Decision Date | 2021-06-11 |