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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, General & Plastic Surgery
510(k) Number K926288
Device Name SOM 6VI (SURGICAL OPERATING MICROSCOPE)
Applicant
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Applicant Contact CRAIG RAPP
Correspondent
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Correspondent Contact CRAIG RAPP
Regulation Number878.4700
Classification Product Code
FSO  
Subsequent Product Code
EPT  
Date Received12/14/1992
Decision Date 10/12/1993
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
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