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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stylet, tracheal tube
510(k) Number K905052
Device Name BIVONA ENDOTRACHEAL TUBE STYLET
Applicant
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Applicant Contact HARRY M KAUFMANN
Correspondent
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Correspondent Contact HARRY M KAUFMANN
Regulation Number868.5790
Classification Product Code
BSR  
Date Received11/08/1990
Decision Date 04/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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