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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 K964369
Device Name TRACH CARE SET WITH MICROBAN
Applicant
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Applicant Contact E. MARTIN CHAMBERLAIN, JR.
Correspondent
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Correspondent Contact E. MARTIN CHAMBERLAIN, JR.
Regulation Number868.6810
Classification Product Code
BSY  
Date Received11/01/1996
Decision Date 02/11/1997
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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