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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 K882891
Device Name A.C.I. TRACH TIE
Applicant
AUXILIARY CARE, INC.
P.O. BOX 144757
CORAL GABLES,  FL  33114
Applicant Contact CARLOS LOPEZ
Correspondent
AUXILIARY CARE, INC.
P.O. BOX 144757
CORAL GABLES,  FL  33114
Correspondent Contact CARLOS LOPEZ
Regulation Number868.5770
Classification Product Code
CBH  
Date Received07/11/1988
Decision Date 09/19/1988
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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