The following data is part of a premarket notification filed by Lil Drug Store Products, Inc. with the FDA for Replens Long-lasting Vaginal Moisturizer (pre-filled Applicator).
| Device ID | K101241 |
| 510k Number | K101241 |
| Device Name: | REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) |
| Classification | Lubricant, Personal |
| Applicant | LIL DRUG STORE PRODUCTS, INC. 1201 CONTINENTAL PL. N.E. Cedar Rapids, IA 52402 |
| Contact | Patricia L Miller |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-04 |
| Decision Date | 2010-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600001041 | K101241 | 000 |
| 00022600987611 | K101241 | 000 |