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FDA 510(k) Application Details - K040220
Device Classification Name
Compressor, Air, Portable
More FDA Info for this Device
510(K) Number
K040220
Device Name
Compressor, Air, Portable
Applicant
EVENT MEDICAL LTD
6A LIOSBAN BUSINESS PARK
TUAM ROAD
GALWAY IE
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Contact
ROBBIE WALSH
Other 510(k) Applications for this Contact
Regulation Number
868.6250
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Classification Product Code
BTI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/02/2004
Decision Date
06/09/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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