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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 K852025
Device Name BRANDT TRACHEAL TUBE(TENTATIVE)
Applicant
MALLINCKRODT CRITICAL CARE
73 QUAKER RD.
GLENS FALLS,  NY  12301
Applicant Contact PHILIP E WIEGERT
Correspondent
MALLINCKRODT CRITICAL CARE
73 QUAKER RD.
GLENS FALLS,  NY  12301
Correspondent Contact PHILIP E WIEGERT
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/08/1985
Decision Date 08/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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