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510(k) K140506

JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2015
Date Received
February 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa

  • K130581 — KONIX STERILE GEL (June 18, 2014)
  • K101952 — KONIX ULTRASOUND GEL (May 27, 2011)

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