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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K040085
Device Name PERSONAL WARMING LUBRICANT
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
HIS  
Date Received01/16/2004
Decision Date 04/20/2004
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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