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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 K862666
Device Name UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
Applicant
MALLINCKRODT CRITICAL CARE
73 QUAKER RD.
GLENS FALLS,  NY  12301
Applicant Contact WIEGERT, PHD
Correspondent
MALLINCKRODT CRITICAL CARE
73 QUAKER RD.
GLENS FALLS,  NY  12301
Correspondent Contact WIEGERT, PHD
Regulation Number868.5730
Classification Product Code
BTR  
Date Received07/14/1986
Decision Date 08/01/1986
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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