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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 K102379
Device Name LTF-Y0009; MAJ-YOO41; XOEV-3D1
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Applicant Contact STACY A KLUESNER, M.S. RAC
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact STACY A KLUESNER, M.S. RAC
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/23/2010
Decision Date 01/05/2011
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
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