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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 K931749
Device Name BIVONA(R) ICU ENDOTRACHEAL TUBE
Applicant
Bivona Medical Technologies
5700 W. 23rd.Ave.
Gary,  IN  46406
Applicant Contact HARRY M KAUFMAN
Correspondent
Bivona Medical Technologies
5700 W. 23rd.Ave.
Gary,  IN  46406
Correspondent Contact HARRY M KAUFMAN
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/08/1993
Decision Date 08/10/1993
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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