MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE

Actuator, Syringe, Injector Type

SPECTRAMED, INC.

The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Model Ta-cs10 Spectraject Control Syringe.

Pre-market Notification Details

Device IDK880740
510k NumberK880740
Device Name:MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
ClassificationActuator, Syringe, Injector Type
Applicant SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
ContactRobert L Leavitt
CorrespondentRobert L Leavitt
SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
Product CodeDQF  
CFR Regulation Number870.1670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-24
Decision Date1988-03-22

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