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FDA 510(k) Application Details - K021931
Device Classification Name
Illuminator, Fiberoptic, Surgical Field
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510(K) Number
K021931
Device Name
Illuminator, Fiberoptic, Surgical Field
Applicant
GULF MEDICAL FIBEROPTICS
376 DOUGLAS RD.
UNIT D
OLDSMAR, FL 34677 US
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Contact
MARCELINO AFANADOR
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Regulation Number
878.4580
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Classification Product Code
HBI
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More FDA Info for this Product Code
Date Received
06/12/2002
Decision Date
09/06/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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