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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 K873732
Device Name TRACH CARE START KIT
Applicant
Ballard Medical Products
2101 L St. NW
Washington,  DC  20037
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Ballard Medical Products
2101 L St. NW
Washington,  DC  20037
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received08/10/1987
Decision Date 10/13/1987
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
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