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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Microsurgical, Without Audio
510(k) Number K862664
Device Name JEDMED CCD CAMERA SYSTEM
Applicant
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Applicant Contact CRAIG RAPP
Correspondent
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Correspondent Contact CRAIG RAPP
Regulation Number878.4160
Classification Product Code
FWD  
Date Received07/14/1986
Decision Date 07/30/1986
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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