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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K870470
Device Name TRACH MATE TRACHEAL TUBE
Applicant
Mccormick Laboratories, Inc.
P.O. Box 948
110 Middlesex St.
North Chelmsford,  MA  01863
Applicant Contact JACOB BLECHER
Correspondent
Mccormick Laboratories, Inc.
P.O. Box 948
110 Middlesex St.
North Chelmsford,  MA  01863
Correspondent Contact JACOB BLECHER
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/03/1987
Decision Date 05/08/1987
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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