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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 K013617
Device Name LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS
Applicant
OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/05/2001
Decision Date 01/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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