FDA 510(k) Application Details - K970378

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

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510(K) Number K970378
Device Name Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Applicant IMPLANT RESOURCE, INC.
11975 PORTLAND AVENUE S.
SUITE 138
MINNEAPOLIS, MN 55337 US
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Contact MICHAEL HOLLOWAY
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Regulation Number 000.0000

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Classification Product Code KIJ
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Date Received 01/31/1997
Decision Date 04/30/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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