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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 K014281
Device Name GARD FILTER, COMBIGARD FILTE / HME
Applicant
MUNKTELL FILTER AB
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Applicant Contact PAUL DRYDEN
Correspondent
MUNKTELL FILTER AB
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Correspondent Contact PAUL DRYDEN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received12/27/2001
Decision Date 06/26/2002
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
Predetermined Change
Control Plan Authorized		 No
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