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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K973557
Device Name LUBRIGLIDE
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 Number880.6375
Classification Product Code
KMJ  
Date Received09/19/1997
Decision Date 10/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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