Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080406
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K080406
Device Name
Powered Laser Surgical Instrument
Applicant
CYDEN LIMITED
TECHNIUM, KINGS ROAD
THE DOCKS
SWANSEA, WALES SA1 8PH GB
Other 510(k) Applications for this Company
Contact
MICHEAL KIERNAN
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/14/2008
Decision Date
03/10/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact