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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 K873461
Device Name LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
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 Received08/28/1987
Decision Date 11/06/1987
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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