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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K853502
Device Name VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
Applicant
Bivona Medical Technologies
5700 W. 23rd.Ave.
Gary,  IN  46406
Applicant Contact SHAPIRO
Correspondent
Bivona Medical Technologies
5700 W. 23rd.Ave.
Gary,  IN  46406
Correspondent Contact SHAPIRO
Regulation Number868.5730
Classification Product Code
BTR  
Date Received08/21/1985
Decision Date 10/01/1985
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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