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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, water purification
510(k) Number K924695
Device Name ASEPTECH PORTABLE RO+ SYSTEM
Applicant
DAYTON WATER SYSTEMS
1288 MCCOOK AVE.
DAYTON,  OH  45404
Applicant Contact DIANE DOLAN
Correspondent
DAYTON WATER SYSTEMS
1288 MCCOOK AVE.
DAYTON,  OH  45404
Correspondent Contact DIANE DOLAN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received09/17/1992
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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