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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K081536
FOIA Releasable 510(k) K081536
Device Name MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
Applicant
Medisize BV
Edisonstraat 1
Hillegom,  NL 2181 AB
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact HARRY J VAN VUGT
Regulation Number868.5260
Classification Product Code
CAH  
Date Received06/02/2008
Decision Date 01/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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