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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lubricant, personal
510(k) Number K053397
Device Name K-Y BRAND SENSUAL MIST
Applicant
MCNEIL-PPC, INC.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Applicant Contact NADER FOTOUHI
Correspondent
MCNEIL-PPC, INC.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Correspondent Contact NADER FOTOUHI
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/06/2005
Decision Date 02/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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