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FDA 510(k) Application Details - K142386
Device Classification Name
Light, Surgical, Accessories
More FDA Info for this Device
510(K) Number
K142386
Device Name
Light, Surgical, Accessories
Applicant
Litex Manufacturing, Inc.
1501 Sunshine Drive
Glendale, CA 91208 US
Other 510(k) Applications for this Company
Contact
Noel Gharibian
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
FTA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/27/2014
Decision Date
09/29/2014
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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