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FDA 510(k) Application Details - K141330
Device Classification Name
Light, Surgical, Fiberoptic
More FDA Info for this Device
510(K) Number
K141330
Device Name
Light, Surgical, Fiberoptic
Applicant
ENROXTECH, INC.
4655 KIRKWOOD COURT
BOULDER, CO 80301 US
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Contact
LEWIS WARD
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
FST
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More FDA Info for this Product Code
Date Received
05/21/2014
Decision Date
12/15/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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