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FDA 510(k) Application Details - K122762
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K122762
Device Name
System, Ablation, Microwave And Accessories
Applicant
MICROSULIS MEDICAL LIMITED
UNIT 1 AND 2 FALSON COURT
PARKLANDS BUSINESS PARK
DENMEAD PO7 7XP GB
Other 510(k) Applications for this Company
Contact
STUART MCINTYRE
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
NEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/10/2012
Decision Date
11/30/2012
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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