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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name illuminator, fiberoptic, surgical field
510(k) Number K920167
Device Name NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL
Applicant
NEXTEC CORP.
2629 S. HORSESHOE DR.
NAPLES,  FL  33942
Applicant Contact JACK KLOOTS
Correspondent
NEXTEC CORP.
2629 S. HORSESHOE DR.
NAPLES,  FL  33942
Correspondent Contact JACK KLOOTS
Regulation Number878.4580
Classification Product Code
HBI  
Date Received01/10/1992
Decision Date 03/23/1992
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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