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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Tracheal Tube
510(k) Number K920691
Device Name THE LEWIS TUBE HOLDER
Applicant
R. Lewis, Inc.
643 Magazine St.
New Orleans,  LA  70130
Applicant Contact LYNNE FRIEDMAN
Correspondent
R. Lewis, Inc.
643 Magazine St.
New Orleans,  LA  70130
Correspondent Contact LYNNE FRIEDMAN
Regulation Number868.5770
Classification Product Code
CBH  
Date Received02/14/1992
Decision Date 03/18/1992
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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