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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 K872277
Device Name TRAKEFIT TRACHEOSTOMY TUBE HOLDER
Applicant
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Applicant Contact BERNARD ACKERMAN,PHD
Correspondent
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Correspondent Contact BERNARD ACKERMAN,PHD
Regulation Number868.5770
Classification Product Code
CBH  
Date Received06/15/1987
Decision Date 07/21/1987
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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