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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elevator, Uterine
510(k) Number K820672
Device Name HASSON BUEC-3
Applicant
Bivona Medical Technologies
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bivona Medical Technologies
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.4530
Classification Product Code
HDP  
Date Received03/11/1982
Decision Date 07/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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