510(k) K070545

K-Y BRAND WARMING LIQUID by Personal Products Co. — Product Code NUC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 23, 2007
Date Received: February 26, 2007
Clearance Type: Special
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 Personal Products Co.

K062796 — K-Y BRAND INTRIGUE (December 8, 2006)
K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (April 30, 2001)
K990536 — O.B. TAMPON (August 31, 1999)
K991118 — O.B. APPLICATOR TAMPONS, O.B. TAMPONS (June 29, 1999)
K974629 — O.B. APPLICATOR AND NON-APPLICATOR TAMPONS (February 10, 1998)
K971589 — REACH ANTIBACTERIAL TOOTHBRUSH (July 24, 1997)
K970954 — O.B. APPLICATOR TAMPONS (June 10, 1997)
K961119 — CAREFREE PANTYLINERS (April 17, 1996)
K953638 — O.B. APPLICATOR TAMPONS (October 20, 1995)
K941863 — O.B. TAMPON (June 27, 1994)

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