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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K850446
Device Name TRACHEOSTOMY CARE KIT
Applicant
Paco Research Corp.
Ellis Pharmaceutical Consultin
913 State Rd.
Princeton,  NJ  08540
Applicant Contact LEVI ELLIS
Correspondent
Paco Research Corp.
Ellis Pharmaceutical Consultin
913 State Rd.
Princeton,  NJ  08540
Correspondent Contact LEVI ELLIS
Regulation Number868.5800
Classification Product Code
BTO  
Date Received02/05/1985
Decision Date 03/11/1985
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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