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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name circuit, breathing (w connector, adaptor, y piece)
510(k) Number K890499
Device Name BIVONA VENTILATOR ISOLATOR SYSTEM
Applicant
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Applicant Contact HARRY M KAUFMAN
Correspondent
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Correspondent Contact HARRY M KAUFMAN
Regulation Number868.5240
Classification Product Code
CAI  
Date Received02/01/1989
Decision Date 06/15/1989
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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