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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, fiberoptic
510(k) Number K921646
Device Name NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
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
FST  
Date Received04/06/1992
Decision Date 05/13/1992
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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