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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 K884098
Device Name THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101
Applicant
AMERICAN BIOSYSTEMS, INC.
P.O. BOX 112
MARINE ON ST. CROIX,  MN  55047
Applicant Contact JUDITH M SHADE
Correspondent
AMERICAN BIOSYSTEMS, INC.
P.O. BOX 112
MARINE ON ST. CROIX,  MN  55047
Correspondent Contact JUDITH M SHADE
Regulation Number868.5665
Classification Product Code
BYI  
Date Received09/28/1988
Decision Date 12/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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