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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 K050212
Device Name PERSONAL WARMING JELLY
Applicant
QUALIS, INC.
4600 PARK AVE.
DES MOINES,  IA  50321
Applicant Contact MIKE PETERSON
Correspondent
QUALIS, INC.
4600 PARK AVE.
DES MOINES,  IA  50321
Correspondent Contact MIKE PETERSON
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/31/2005
Decision Date 03/17/2005
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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