CALIBRATOR, DYNAMIC

Densitometer

WATERS ASSOC., INC.

The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Calibrator, Dynamic.

Pre-market Notification Details

Device IDK781692
510k NumberK781692
Device Name:CALIBRATOR, DYNAMIC
ClassificationDensitometer
Applicant WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXM  
CFR Regulation Number870.1450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-10-04
Decision Date1978-11-29

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