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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K875346
Device Name AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)
Applicant
CONTRAVES MEDICAL INSTRUMENTS, INC.
44 MANNING RD.
BILLERICA,  MA  01821
Applicant Contact DAVID BERTOLAMI
Correspondent
CONTRAVES MEDICAL INSTRUMENTS, INC.
44 MANNING RD.
BILLERICA,  MA  01821
Correspondent Contact DAVID BERTOLAMI
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received12/31/1987
Decision Date 04/07/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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