THE STORK OTC

Kit, Conception-assist, Home Use

RINOVUM WOMEN'S HEALTH, INC

The following data is part of a premarket notification filed by Rinovum Women's Health, Inc with the FDA for The Stork Otc.

Pre-market Notification Details

Device IDK140186
510k NumberK140186
Device Name:THE STORK OTC
ClassificationKit, Conception-assist, Home Use
Applicant RINOVUM WOMEN'S HEALTH, INC 300 Oxford Dr Suite 330 Monroeville,  PA  15146
ContactAndrew Zeltwanger
CorrespondentAndrew Zeltwanger
RINOVUM WOMEN'S HEALTH, INC 300 Oxford Dr Suite 330 Monroeville,  PA  15146
Product CodeOBB  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-24
Decision Date2014-07-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810396020335 K140186 000
00810396020311 K140186 000
00810396020304 K140186 000
00810396020199 K140186 000
00810396020090 K140186 000
00810396020083 K140186 000
00810396020007 K140186 000

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