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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 K872621
Device Name TRACH CARE CATHETER
Applicant
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact ERNEST CHAMBERLAIN
Correspondent
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact ERNEST CHAMBERLAIN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received07/06/1987
Decision Date 09/15/1987
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
Recalls CDRH Recalls
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