EDSLAB PRESSURE GAUGE

Syringe, Balloon Inflation

AMERICAN EDWARDS LABORATORIES

The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Edslab Pressure Gauge.

Pre-market Notification Details

Device IDK832323
510k NumberK832323
Device Name:EDSLAB PRESSURE GAUGE
ClassificationSyringe, Balloon Inflation
Applicant AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-15
Decision Date1983-08-11

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