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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 K013093
Device Name PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
Applicant
Pall Medical
600 S Wagner Rd.
Ann Arbor,  MI  48103
Applicant Contact LEONARD S BERMAN
Correspondent
Pall Medical
600 S Wagner Rd.
Ann Arbor,  MI  48103
Correspondent Contact LEONARD S BERMAN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/17/2001
Decision Date 08/01/2002
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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