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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K024301
Device Name LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
Applicant
Lsi Solutions
7796 Victor-Mendon Rd.
Victor,  NY  14564
Applicant Contact CHRISTOPHER A KLACZYK
Correspondent
Lsi Solutions
7796 Victor-Mendon Rd.
Victor,  NY  14564
Correspondent Contact CHRISTOPHER A KLACZYK
Regulation Number876.1500
Classification Product Code
ODC  
Date Received12/24/2002
Decision Date 03/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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