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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 K792035
Device Name FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
Applicant
Bivona Medical Technologies
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bivona Medical Technologies
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5730
Classification Product Code
BTR  
Date Received10/10/1979
Decision Date 10/26/1979
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
Recalls CDRH Recalls
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