FINE NEEDLE ASPIRATION DEVICE

Compressor, Cardiac, External

GYNECO, INC.

The following data is part of a premarket notification filed by Gyneco, Inc. with the FDA for Fine Needle Aspiration Device.

Pre-market Notification Details

Device IDK841275
510k NumberK841275
Device Name:FINE NEEDLE ASPIRATION DEVICE
ClassificationCompressor, Cardiac, External
Applicant GYNECO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDRM  
CFR Regulation Number870.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-27
Decision Date1984-08-17

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