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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 K142482
Device Name The Vest Airway Clearance System
Applicant
Hill-Rom Services Private Limited
1 Yishum Ave. 7
Singapore,  SG 768923
Applicant Contact Christina Miracle
Correspondent
Promedic, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number868.5665
Classification Product Code
BYI  
Date Received09/04/2014
Decision Date 05/07/2015
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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