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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 K021931
Device Name ENDOSCOPIC FIBEROPTIC CABLE
Applicant
Gulf Medical Fiberoptics
376 Douglas Rd.
Unit D
Oldsmar,  FL  34677
Applicant Contact MARCELINO AFANADOR
Correspondent
Gulf Medical Fiberoptics
376 Douglas Rd.
Unit D
Oldsmar,  FL  34677
Correspondent Contact MARCELINO AFANADOR
Regulation Number878.4580
Classification Product Code
HBI  
Subsequent Product Code
FFS  
Date Received06/12/2002
Decision Date 09/06/2002
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
Predetermined Change
Control Plan Authorized		 No
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