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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percussor, Powered-Electric
510(k) Number K122480
Device Name INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
Applicant
International Biophysics Corporation
2101 E. St. Elmo Rd.
Suite 275
Austin,  TX  78744
Applicant Contact H. DAVID SHOCKLEY JR.
Correspondent
International Biophysics Corporation
2101 E. St. Elmo Rd.
Suite 275
Austin,  TX  78744
Correspondent Contact H. DAVID SHOCKLEY JR.
Regulation Number868.5665
Classification Product Code
BYI  
Date Received08/14/2012
Decision Date 03/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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