Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K052979
Device Classification Name
Illuminator, Fiberoptic, Surgical Field
More FDA Info for this Device
510(K) Number
K052979
Device Name
Illuminator, Fiberoptic, Surgical Field
Applicant
ISOLUX LLC
1045 COLLIER CENTER WAY
SUITE #6
NAPLES, FL 34110-8444 US
Other 510(k) Applications for this Company
Contact
NILCOLAOS ANDREOULAKIS
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
HBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/24/2005
Decision Date
10/31/2005
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
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact