UTERINE SOUND

Sound, Uterine

GYNEMETRICS, INC.

The following data is part of a premarket notification filed by Gynemetrics, Inc. with the FDA for Uterine Sound.

Pre-market Notification Details

Device IDK802315
510k NumberK802315
Device Name:UTERINE SOUND
ClassificationSound, Uterine
Applicant GYNEMETRICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHHM  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-09-23
Decision Date1981-01-12

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