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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K023630
Device Name ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
Applicant
Guidant Corporation, Cardiac Surgery
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact RON ALLEN
Correspondent
N.V. Kema
P.O. Box 9035
6800 Et Arnhem
Arnhem,  NL
Correspondent Contact MICHELLE WEIDMAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/28/2002
Decision Date 02/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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