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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 K860901
Device Name LASER RESISTANT TRACHEAL TUBE (TENTATIVE)
Applicant
MALLINCKRODT CRITICAL CARE
73 QUAKER RD.
GLENS FALLS,  NY  12301
Applicant Contact WIEGART, PHD
Correspondent
MALLINCKRODT CRITICAL CARE
73 QUAKER RD.
GLENS FALLS,  NY  12301
Correspondent Contact WIEGART, PHD
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/10/1986
Decision Date 06/05/1986
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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