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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Abortion Unit, Vacuum
510(k) Number K905115
Device Name BIOVISION ENDOCULAR PROBE
Applicant
Douglas James Donaldson Compliance Services
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Applicant Contact DOUGLAS DONALDSON
Correspondent
Douglas James Donaldson Compliance Services
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Correspondent Contact DOUGLAS DONALDSON
Regulation Number884.5070
Classification Product Code
HGF  
Date Received11/13/1990
Decision Date 02/11/1991
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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