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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K040220
Device Name MEDICAL AIR COMPRESSOR
Applicant
EVENT MEDICAL LTD
6A LIOSBAN BUSINESS PARK
TUAM ROAD
GALWAY,  IE
Applicant Contact ROBBIE WALSH
Correspondent
EVENT MEDICAL LTD
6A LIOSBAN BUSINESS PARK
TUAM ROAD
GALWAY,  IE
Correspondent Contact ROBBIE WALSH
Regulation Number868.6250
Classification Product Code
BTI  
Date Received02/02/2004
Decision Date 06/09/2004
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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