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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K123319
Device Name GYRUS ACMI BICOAG HEMOSTASIS PROBE
Applicant
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
136 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Applicant Contact NEIL KELLY
Correspondent
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
136 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Correspondent Contact NEIL KELLY
Regulation Number876.4300
Classification Product Code
KNS  
Date Received10/26/2012
Decision Date 12/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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