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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 K802713
Device Name FMS-02 FLOOR-UNIT MODEL MICROSCOPE
Applicant
JEDMED INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
JEDMED INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4700
Classification Product Code
FSO  
Date Received10/31/1980
Decision Date 11/19/1980
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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