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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 K965192
Device Name THAIRAPY VEST SYSTEM
Applicant
AMERICAN BIOSYSTEMS, INC.
1375 WOLTERS BLVD., SUITE 116
ST.PAUL,  MN  55110
Applicant Contact PHILLIP ROSE
Correspondent
AMERICAN BIOSYSTEMS, INC.
1375 WOLTERS BLVD., SUITE 116
ST.PAUL,  MN  55110
Correspondent Contact PHILLIP ROSE
Regulation Number868.5665
Classification Product Code
BYI  
Date Received12/24/1996
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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