DIGICELL 500

Counter, Cell, Automated (particle Counter)

CONTRAVES MEDICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Contraves Medical Instruments, Inc. with the FDA for Digicell 500.

Pre-market Notification Details

Device IDK873252
510k NumberK873252
Device Name:DIGICELL 500
ClassificationCounter, Cell, Automated (particle Counter)
Applicant CONTRAVES MEDICAL INSTRUMENTS, INC. 44 MANNING RD. Billerica,  MA  01821
ContactDavid B Bertolami
CorrespondentDavid B Bertolami
CONTRAVES MEDICAL INSTRUMENTS, INC. 44 MANNING RD. Billerica,  MA  01821
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-17
Decision Date1987-11-06

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