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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 K903412
Device Name STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact SUSAN SMITH
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact SUSAN SMITH
Regulation Number878.4700
Classification Product Code
EPT  
Date Received07/30/1990
Decision Date 09/20/1990
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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