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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K903058
Device Name BACT-HME (TM)
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 Number868.5375
Classification Product Code
BYD  
Date Received07/11/1990
Decision Date 11/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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