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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 K012928
Device Name ABI VEST AIRWAY CLEARANCE SYSTEM
Applicant
Advanced Respiratory
1020 W. County Rd. F
St. Paul,  MN  55126
Applicant Contact ERIC J LARSON
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number868.5665
Classification Product Code
BYI  
Date Received08/31/2001
Decision Date 10/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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