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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 K024270
Device Name CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3
Applicant
Intersurgical, Inc.
417 Electronics Pkwy.
Liverpool,  NY  13088
Applicant Contact THOMAS R GUNERMAN
Correspondent
Intersurgical, Inc.
417 Electronics Pkwy.
Liverpool,  NY  13088
Correspondent Contact THOMAS R GUNERMAN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received12/23/2002
Decision Date 06/24/2003
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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