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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K934066
Device Name NEPHRETECT
Applicant
Alden Scientific, Inc.
550 Pleasant St.
Winthrop,  MA  02152
Applicant Contact ADOLPH E D'AMICO
Correspondent
Alden Scientific, Inc.
550 Pleasant St.
Winthrop,  MA  02152
Correspondent Contact ADOLPH E D'AMICO
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/20/1993
Decision Date 05/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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