SFA MODULE

Computer, Diagnostic, Pre-programmed, Single-function

LIFE SCIENCES MANUFACTURING, INC.

The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Sfa Module.

Pre-market Notification Details

Device IDK896528
510k NumberK896528
Device Name:SFA MODULE
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon,  NH  03784
ContactRobert S Cutler
CorrespondentRobert S Cutler
LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon,  NH  03784
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-16
Decision Date1990-01-26

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