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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 K791086
Device Name CENTRY 2 SYSTEM #016, 103, 016, 104
Applicant
COBE LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COBE LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/12/1979
Decision Date 07/03/1979
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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