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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 K852272
Device Name BIVONA TRACHEOSTOMA VALVE II
Applicant
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Applicant Contact SHAPIRO, M.D.
Correspondent
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Correspondent Contact SHAPIRO, M.D.
Regulation Number868.5800
Classification Product Code
BTO  
Date Received05/28/1985
Decision Date 07/08/1985
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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