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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 K123770
Device Name WARMING JELLY PERSONAL LUBRICANT
Applicant
WISCONSIN PHARMACAL CO., LLC
1 PHARMACAL WAY
JACKSON,  WI  53037
Applicant Contact JOHN NYGAARD
Correspondent
WISCONSIN PHARMACAL CO., LLC
1 PHARMACAL WAY
JACKSON,  WI  53037
Correspondent Contact JOHN NYGAARD
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/07/2012
Decision Date 04/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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