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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, ceiling mounted
510(k) Number K042382
Device Name DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
Applicant
MED-GENERAL TECHNOLOGIES LLC
1016 COLLIER CENTER WAY
SUITE 102
NAPLES,  FL  34110
Applicant Contact PAUL MCCREIGHT
Correspondent
MED-GENERAL TECHNOLOGIES LLC
1016 COLLIER CENTER WAY
SUITE 102
NAPLES,  FL  34110
Correspondent Contact PAUL MCCREIGHT
Regulation Number878.4580
Classification Product Code
FSY  
Date Received09/01/2004
Decision Date 11/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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