FDA 510(k) Application Details - K050766

Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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510(K) Number K050766
Device Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant ZIMMER TRABECULAR
80 COMMERCE DR.
ALLENDALE, NJ 07401 US
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Contact MARCI HALEVI
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Regulation Number 878.4820

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Classification Product Code HWE
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Date Received 03/25/2005
Decision Date 05/26/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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