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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 K951410
Device Name DISPOSABLE PULMONARY FUNCTION FILTER
Applicant
Creative Biomedics, Inc.
934-B Calle Negocio
San Clemente,  CA  92673
Applicant Contact DANIEL BROWN
Correspondent
Creative Biomedics, Inc.
934-B Calle Negocio
San Clemente,  CA  92673
Correspondent Contact DANIEL BROWN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received03/27/1995
Decision Date 04/24/1995
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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