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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lamp, surgical, incandescent
510(k) Number K896961
Device Name HALUX EXLITE MINOR SURGERY 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 Number878.4580
Classification Product Code
GBC  
Date Received12/15/1989
Decision Date 02/22/1990
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
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