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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 K973780
Device Name PERSONAL LUBRICATING LIQUID
Applicant
QUALIS, INC.
4600 PARK AVE.
DES MOINES,  IA  50321
Applicant Contact MARY A FINN
Correspondent
QUALIS, INC.
4600 PARK AVE.
DES MOINES,  IA  50321
Correspondent Contact MARY A FINN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/03/1997
Decision Date 11/26/1997
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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