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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 K993629
Device Name ABI VEST AIRWAY CLEARANCE SYSTEM
Applicant
AMERICAN BIOSYSTEMS, INC.
20 YORKTON CT.
ST. PAUL,  MN  55117
Applicant Contact ERIC J LARSON
Correspondent
AMERICAN BIOSYSTEMS, INC.
20 YORKTON CT.
ST. PAUL,  MN  55117
Correspondent Contact ERIC J LARSON
Regulation Number868.5665
Classification Product Code
BYI  
Date Received10/27/1999
Decision Date 01/21/2000
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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