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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 K032322
Device Name CLEAR-THERM MICRO HME, MODEL 1441
Applicant
Intersurgical, Inc.
417 Electronics Pkwy.
Liverpool,  NY  13088
Applicant Contact MICHAEL ZALEWSKI
Correspondent
Intersurgical, Inc.
417 Electronics Pkwy.
Liverpool,  NY  13088
Correspondent Contact MICHAEL ZALEWSKI
Regulation Number868.5260
Classification Product Code
CAH  
Date Received07/28/2003
Decision Date 05/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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