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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 K864535
Device Name TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
Applicant
Concord Laboratories, Inc.
Kit St.
Keene,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
Concord Laboratories, Inc.
Kit St.
Keene,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number868.6810
Classification Product Code
BSY  
Date Received11/17/1986
Decision Date 01/06/1987
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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