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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 K072002
Device Name FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
Applicant
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Applicant Contact KATHY ANDERSON
Correspondent
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact KATHY ANDERSON
Regulation Number868.5260
Classification Product Code
CAH  
Date Received07/23/2007
Decision Date 01/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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