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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, capillary, hollow fiber
510(k) Number K905779
Device Name ALDETECT
Applicant
POCHEMCO, INC.
861 MEADOW ST.
CHICOPEE,  MA  01013
Applicant Contact JERRY POCH
Correspondent
POCHEMCO, INC.
861 MEADOW ST.
CHICOPEE,  MA  01013
Correspondent Contact JERRY POCH
Regulation Number876.5820
Classification Product Code
FJI  
Date Received12/27/1990
Decision Date 05/23/1991
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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