PAN-AM MYELOGRAM TRAY

Needle, Hypodermic, Single Lumen

WATERS ASSOC., INC.

The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Pan-am Myelogram Tray.

Pre-market Notification Details

Device IDK801431
510k NumberK801431
Device Name:PAN-AM MYELOGRAM TRAY
ClassificationNeedle, Hypodermic, Single Lumen
Applicant WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-06-18
Decision Date1980-08-12

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