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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Abortion, Vacuum
510(k) Number K862476
Device Name LS3000 CANNULA UTERINE SUCTION
Applicant
Engineering, Inc.
214 Lincoln Center Dr.
Foster City,  CA  94404
Applicant Contact ROBERT LASH
Correspondent
Engineering, Inc.
214 Lincoln Center Dr.
Foster City,  CA  94404
Correspondent Contact ROBERT LASH
Regulation Number884.5070
Classification Product Code
HHI  
Date Received06/30/1986
Decision Date 07/18/1986
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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