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FDA 510(k) Application Details - K991208
Device Classification Name
Illuminator, Fiberoptic, Surgical Field
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510(K) Number
K991208
Device Name
Illuminator, Fiberoptic, Surgical Field
Applicant
ISOLUX AMERICA
1479 RAILHEAD BLVD.
NAPLES, FL 34110-8444 US
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Contact
STUART L MCGHEE
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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
04/09/1999
Decision Date
06/23/1999
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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