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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K944178
Device Name BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
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 Number868.5800
Classification Product Code
JOH  
Date Received08/26/1994
Decision Date 10/27/1994
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
Recalls CDRH Recalls
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