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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K873271
Device Name DIGICELL 300 SYSTEM
Applicant
Contraves Medical Instruments, Inc.
44 Manning Rd.
Billerica,  MA  01821
Applicant Contact DAVID B BERTOLAMI
Correspondent
Contraves Medical Instruments, Inc.
44 Manning Rd.
Billerica,  MA  01821
Correspondent Contact DAVID B BERTOLAMI
Regulation Number864.5200
Classification Product Code
GKL  
Date Received08/17/1987
Decision Date 11/06/1987
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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