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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic ultrasound system, gastroenterology-urology
510(k) Number K926514
Device Name ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20
Applicant
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Applicant Contact BARRY E SANDS
Correspondent
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Correspondent Contact BARRY E SANDS
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Codes
FDF   FDS   FDT  
Date Received12/30/1992
Decision Date 08/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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