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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K850864
Device Name TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO
Applicant
PACO RESEARCH CORP.
ELLIS PHARMACEUTICAL CONSULTIN
913 STATE ROAD
PRINCETON,  NJ  08540
Applicant Contact LEVI ELLIS
Correspondent
PACO RESEARCH CORP.
ELLIS PHARMACEUTICAL CONSULTIN
913 STATE ROAD
PRINCETON,  NJ  08540
Correspondent Contact LEVI ELLIS
Regulation Number868.6810
Classification Product Code
BSY  
Date Received03/01/1985
Decision Date 05/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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