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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ligator, Esophageal
510(k) Number K013066
Device Name HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
Applicant
Olympus America, Inc.
2 Corporate Center Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus America, Inc.
2 Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.4400
Classification Product Code
MND  
Date Received09/12/2001
Decision Date 12/11/2001
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
Recalls CDRH Recalls
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