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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 K896116
Device Name ENTRAPPING FILTER
Applicant
Cadema Medical Products, Inc.
P.O. Box 250
Middletown,  NY  10940
Applicant Contact KATHLEEN D BORDONI
Correspondent
Cadema Medical Products, Inc.
P.O. Box 250
Middletown,  NY  10940
Correspondent Contact KATHLEEN D BORDONI
Regulation Number868.5260
Classification Product Code
CAH  
Date Received10/20/1989
Decision Date 11/17/1989
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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