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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, reusable
510(k) Number K862749
Device Name LS9000 SUCTION BIOPSY NEEDLE
Applicant
ENGINEERING, INC.
214 LINCOLN CENTER DR.
FOSTER CITY,  CA  94404
Applicant Contact LASH, MD
Correspondent
ENGINEERING, INC.
214 LINCOLN CENTER DR.
FOSTER CITY,  CA  94404
Correspondent Contact LASH, MD
Regulation Number878.4800
Classification Product Code
GDM  
Date Received07/21/1986
Decision Date 09/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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