INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST

Percussor, Powered-electric

INTERNATIONAL BIOPHYSICS CORPORATION

The following data is part of a premarket notification filed by International Biophysics Corporation with the FDA for International Biophysics Corporation Afflovest.

Pre-market Notification Details

Device IDK122480
510k NumberK122480
Device Name:INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
ClassificationPercussor, Powered-electric
Applicant INTERNATIONAL BIOPHYSICS CORPORATION 2101 E. ST ELMO ROAD SUITE 275 Austin,  TX  78744
ContactH. David Shockley Jr.
CorrespondentH. David Shockley Jr.
INTERNATIONAL BIOPHYSICS CORPORATION 2101 E. ST ELMO ROAD SUITE 275 Austin,  TX  78744
Product CodeBYI  
CFR Regulation Number868.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-14
Decision Date2013-03-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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