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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 K911651
Device Name ZEFON BATERIAL/VIRAL FILTER
Applicant
Bill Olson Corp.
5350 SW First Ln.
Ocala,  FL  34474
Applicant Contact MICHAEL BYRNE
Correspondent
Bill Olson Corp.
5350 SW First Ln.
Ocala,  FL  34474
Correspondent Contact MICHAEL BYRNE
Regulation Number868.5260
Classification Product Code
CAH  
Date Received04/12/1991
Decision Date 05/30/1991
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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