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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 K850265
Device Name AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE
Applicant
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Applicant Contact LAWRENCE W GETTLIN
Correspondent
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Correspondent Contact LAWRENCE W GETTLIN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received01/23/1985
Decision Date 04/05/1985
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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