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 (35g Tube With Reusable Applicator) Model: 83035.
Device ID | K101098 |
510k Number | K101098 |
Device Name: | REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 |
Classification | Lubricant, Personal |
Applicant | LIL DRUG STORE PRODUCTS, INC. 1201 CONTINENTAL PL. N.E. Cedar Rapids, IA 52402 |
Contact | Patricia 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 | 2010-04-20 |
Decision Date | 2010-08-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00311917184616 | K101098 | 000 |
00022600987611 | K101098 | 000 |
00022600001072 | K101098 | 000 |