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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 K903056
Device Name BACTTRAP
Applicant
Pharma Systems, Inc.
32 Oak Place
Bernardsville,  NJ  07924
Applicant Contact HAL NORRIS
Correspondent
Pharma Systems, Inc.
32 Oak Place
Bernardsville,  NJ  07924
Correspondent Contact HAL NORRIS
Regulation Number868.5260
Classification Product Code
CAH  
Date Received07/11/1990
Decision Date 11/05/1990
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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