THE OB-GYN CONCEPTS VAGINAL ASPIRATOR

Instrument, Manual, General Obstetric-gynecologic

OB/GYN CONCEPTS, LTD.

The following data is part of a premarket notification filed by Ob/gyn Concepts, Ltd. with the FDA for The Ob-gyn Concepts Vaginal Aspirator.

Pre-market Notification Details

Device IDK863610
510k NumberK863610
Device Name:THE OB-GYN CONCEPTS VAGINAL ASPIRATOR
ClassificationInstrument, Manual, General Obstetric-gynecologic
Applicant OB/GYN CONCEPTS, LTD. 613 DOCK DR. Barrington,  IL  60010
ContactCharles B Root
CorrespondentCharles B Root
OB/GYN CONCEPTS, LTD. 613 DOCK DR. Barrington,  IL  60010
Product CodeKOH  
CFR Regulation Number884.4520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-16
Decision Date1987-01-07

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