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FDA 510(k) Application Details - K063531
Device Classification Name
Instrument, Ultrasonic Surgical
More FDA Info for this Device
510(K) Number
K063531
Device Name
Instrument, Ultrasonic Surgical
Applicant
SRA DEVELOPMENTS, LTD.
BREMRIDGE HOUSE
ASHBURTON, DEVON TQ13 7JX GB
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Contact
MICHAEL J.R. YOUNG
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/22/2006
Decision Date
02/22/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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