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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mediastinoscope, Surgical
510(k) Number K930215
Device Name FLEXIBLE TROCAR TUBES
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 Number874.4720
Classification Product Code
EWY  
Date Received01/14/1993
Decision Date 03/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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