MSI-PC

Control, Platelet

MEDICAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Msi-pc.

Pre-market Notification Details

Device IDK880608
510k NumberK880608
Device Name:MSI-PC
ClassificationControl, Platelet
Applicant MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield,  NJ  07080
ContactRon Devita
CorrespondentRon Devita
MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield,  NJ  07080
Product CodeGJP  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-12
Decision Date1988-03-21

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