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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 K895233
Device Name BACTERIAL AND VIRAL FILTER
Applicant
F.L.W. Plastics, Inc.
4920 N. Warren Dr.
Columbus,  IN  47203
Applicant Contact D STRUTHERS
Correspondent
F.L.W. Plastics, Inc.
4920 N. Warren Dr.
Columbus,  IN  47203
Correspondent Contact D STRUTHERS
Regulation Number868.5260
Classification Product Code
CAH  
Date Received08/21/1989
Decision Date 11/15/1989
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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