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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Surgical
510(k) Number K812234
Device Name STORZ/OLYMPUS MICROSCOPE SYSTEM
Applicant
STORZ INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
STORZ INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4700
Classification Product Code
EPT  
Date Received08/11/1981
Decision Date 09/11/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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