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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 K843790
Device Name TRACHEAL TUBE FIXATION DEVICE
Applicant
LAERDAL CALIFORNIA, INC.
2841 EAST 19TH. STREET
LONG BEACH,  CA  90804 -
Applicant Contact GEOFFREY C GARTH
Correspondent
LAERDAL CALIFORNIA, INC.
2841 EAST 19TH. STREET
LONG BEACH,  CA  90804 -
Correspondent Contact GEOFFREY C GARTH
Regulation Number868.5770
Classification Product Code
CBH  
Date Received09/27/1984
Decision Date 03/11/1985
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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