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510(k) K101098

REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 by Lil Drug Store Products, Inc. — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2010
Date Received
April 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

Other clearances by Lil Drug Store Products, Inc.

  • K101241 — REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) (August 17, 2010)
  • K072414 — CRYOSTAT (April 7, 2008)

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