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FDA 510(k) Application Details - K083284
Device Classification Name
Instrument, Surgical, Sonic And Accessory/Attachment
More FDA Info for this Device
510(K) Number
K083284
Device Name
Instrument, Surgical, Sonic And Accessory/Attachment
Applicant
PIEZOSURGERY SRL
PIAZZA ALBANIA 10
ROME 00153 IT
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Contact
ROGER GRAY
Other 510(k) Applications for this Contact
Regulation Number
888.4580
More FDA Info for this Regulation Number
Classification Product Code
JDX
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More FDA Info for this Product Code
Date Received
11/07/2008
Decision Date
04/08/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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