TEFLON UTERINE SOUND

Sound, Uterine

COOK OB/GYN

The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Teflon Uterine Sound.

Pre-market Notification Details

Device IDK870550
510k NumberK870550
Device Name:TEFLON UTERINE SOUND
ClassificationSound, Uterine
Applicant COOK OB/GYN 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington,  IN  47402
ContactDexter J Elkins
CorrespondentDexter J Elkins
COOK OB/GYN 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington,  IN  47402
Product CodeHHM  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-10
Decision Date1987-03-04

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