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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 K092451
Device Name INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
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 Received08/10/2009
Decision Date 10/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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