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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 K871204
Device Name CUFFED TRACHEAL TUBE (MULTIPLE)
Applicant
MALLINCKRODT CRITICAL CARE
HOOK RD.
ARGYLE,  NY  12809
Applicant Contact E WIEGERT,PHD
Correspondent
MALLINCKRODT CRITICAL CARE
HOOK RD.
ARGYLE,  NY  12809
Correspondent Contact E WIEGERT,PHD
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/25/1987
Decision Date 04/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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