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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stylet, tracheal tube
510(k) Number K905133
Device Name STYLET TRACHAEL TUBE
Applicant
MEDICAL DEVICES, INC.
952 SOUTH ZEPHYR COURT
LAKEWOOD,  CO  80226
Applicant Contact DAVID CHENOWETH
Correspondent
MEDICAL DEVICES, INC.
952 SOUTH ZEPHYR COURT
LAKEWOOD,  CO  80226
Correspondent Contact DAVID CHENOWETH
Regulation Number868.5790
Classification Product Code
BSR  
Date Received11/15/1990
Decision Date 04/22/1991
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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