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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K895946
Device Name BIVONA CARDEN INTERMITTENT JETTING DEVICE
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 Number868.5925
Classification Product Code
BTL  
Date Received10/11/1989
Decision Date 01/09/1990
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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