FDA 510(k) Application Details - K122480

Device Classification Name Percussor, Powered-Electric

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510(K) Number K122480
Device Name Percussor, Powered-Electric
Applicant INTERNATIONAL BIOPHYSICS CORPORATION
2101 E. ST ELMO ROAD
SUITE 275
AUSTIN, TX 78744 US
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Contact H. DAVID SHOCKLEY JR.
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Regulation Number 868.5665

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Classification Product Code BYI
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Date Received 08/14/2012
Decision Date 03/27/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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