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FDA 510(k) Application Details - K970378
Device Classification Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KIJ
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More FDA Info for this Product Code
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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