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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 K924551
Device Name ENDO TRACHEA TUBE FIXATION
Applicant
M. Imonti and Associates Inc.,
25707 Compass Way
San Juan Capistrano,  CA  92675
Applicant Contact MAURICE IMONTI
Correspondent
M. Imonti and Associates Inc.,
25707 Compass Way
San Juan Capistrano,  CA  92675
Correspondent Contact MAURICE IMONTI
Regulation Number868.5770
Classification Product Code
CBH  
Date Received09/09/1992
Decision Date 12/08/1992
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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