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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 K023627
Device Name ESSEX ENDOSCOPE, MODEL SXD-1000
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact ANNE SCHLAGENHAFT
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 11/12/2002
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
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