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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 (W/Wo Connector)
510(k) Number K912469
Device Name BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
Applicant
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Applicant Contact HARRY A KAUFMAN
Correspondent
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Correspondent Contact HARRY A KAUFMAN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/04/1991
Decision Date 06/19/1991
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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