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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 K844858
Device Name STORZ/URBAN SURGICAL MICROSCOPE SYSTEM
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact TOM GRANT
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact TOM GRANT
Regulation Number878.4700
Classification Product Code
EPT  
Date Received12/14/1984
Decision Date 03/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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