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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K896962
Device Name TINY HALOGEN EXAM LIGHT
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 Number880.6320
Classification Product Code
KZF  
Date Received12/15/1989
Decision Date 12/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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