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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Obstetrical
510(k) Number K914552
Device Name CMI VACUUM PUMP
Applicant
Columbia Medical & Surgical, Inc.
P.O. Box 5877
Bend,  OR  97708
Applicant Contact BEVERLEE LOUVRING
Correspondent
Columbia Medical & Surgical, Inc.
P.O. Box 5877
Bend,  OR  97708
Correspondent Contact BEVERLEE LOUVRING
Regulation Number884.4400
Classification Product Code
HDA  
Date Received10/11/1991
Decision Date 09/07/1993
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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