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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 K941470
Device Name TRACHEOSTOMY CARE KIT
Applicant
CLINICAL RESOURCES, INC.
825A TOLLGATE RD.
ELGIN,  IL  60123
Applicant Contact DAVID INSCO
Correspondent
CLINICAL RESOURCES, INC.
825A TOLLGATE RD.
ELGIN,  IL  60123
Correspondent Contact DAVID INSCO
Regulation Number868.5800
Classification Product Code
BTO  
Date Received03/28/1994
Decision Date 02/14/1995
Decision Substantially Equivalent - Kit (SESK)
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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