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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurosurgical ultrasonic instruments
510(k) Number K962952
Device Name OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)
Applicant
OLYMPUS OPTICAL, CO.
55 NORTHERN BLVD., SUITE 410
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
OLYMPUS OPTICAL, CO.
55 NORTHERN BLVD., SUITE 410
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Classification Product Code
LBK  
Date Received07/30/1996
Decision Date 11/29/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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