FDA 510(k) Application Details - K072961

Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment

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510(K) Number K072961
Device Name Instrument, Surgical, Sonic And Accessory/Attachment
Applicant SRA DEVELOPMENTS, LTD.
BREMRIDGE HOUSE
ASHBURTON, DEVON TQ13 7JX GB
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Contact MICHAEL J.R. YOUNG
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Regulation Number 888.4580

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Classification Product Code JDX
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Date Received 10/19/2007
Decision Date 12/19/2007
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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