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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractor, Vacuum, Fetal
510(k) Number K915763
Device Name MODIFIED DISPOSABLE FETAL VACUUM
Applicant
Columbia Medical & Surgical, Inc.
P.O. Box 5877
Bend,  OR  97708
Applicant Contact BEVERLEE LOURING
Correspondent
Columbia Medical & Surgical, Inc.
P.O. Box 5877
Bend,  OR  97708
Correspondent Contact BEVERLEE LOURING
Regulation Number884.4340
Classification Product Code
HDB  
Date Received12/24/1991
Decision Date 03/18/1992
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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