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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 K942395
Device Name ENDOTRACHEAL TUBE HOLDER
Applicant
S.T.I. Medical Products Corp.
351 N. Newport Blvd. #450
Newport Beach,  CA  92663
Applicant Contact STEVE ISLAVA
Correspondent
S.T.I. Medical Products Corp.
351 N. Newport Blvd. #450
Newport Beach,  CA  92663
Correspondent Contact STEVE ISLAVA
Regulation Number868.5770
Classification Product Code
CBH  
Date Received05/19/1994
Decision Date 06/30/1994
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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