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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coagulator-cutter, endoscopic, bipolar (and accessories)
510(k) Number K142525
Device Name PK Lap Loop
Applicant
Olympus Winter & Ibe GmbH
Kuehnstrasse 61
Hamburg,  DE 22045
Applicant Contact Graham A.L. Baillie
Correspondent
Olympus Surgical Tech America, Gyrus ACMI, Inc.
136 Turnpike Road
Southborough,  MA  01772
Correspondent Contact Graham A.L. Baillie
Regulation Number884.4150
Classification Product Code
HIN  
Date Received09/08/2014
Decision Date 11/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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