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FDA 510(k) Application Details - K131894
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K131894
Device Name
Powered Laser Surgical Instrument
Applicant
NIDEK CO., LTD.
34-14 MAEHAMA, HIROISHI-CHO
GAMAGORI, AICHI 443-0038 JP
Other 510(k) Applications for this Company
Contact
YONEJI MIZUNO
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
06/25/2013
Decision Date
10/31/2013
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
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