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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 K061690
Device Name SURGICAL HEADLIGHT
Applicant
GULF MEDICAL FIBEROPTICS
148 DUNBAR AVE., UNIT B
OLDSMAR,  FL  34677
Applicant Contact MARCELINO AFANADOR
Correspondent
GULF MEDICAL FIBEROPTICS
148 DUNBAR AVE., UNIT B
OLDSMAR,  FL  34677
Correspondent Contact MARCELINO AFANADOR
Regulation Number878.4580
Classification Product Code
FST  
Date Received06/15/2006
Decision Date 09/15/2006
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
Recalls CDRH Recalls
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