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FDA 510(k) Application Details - K983882
Device Classification Name
Spatula, Orthopedic
More FDA Info for this Device
510(K) Number
K983882
Device Name
Spatula, Orthopedic
Applicant
MICRO-MEDICAL DEVICES, INC.
11000 CEDAR AVE.
SUITE 445
CLEVELAND, OH 44106 US
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Contact
JIM OHNECK
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Regulation Number
878.4800
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Classification Product Code
HXR
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More FDA Info for this Product Code
Date Received
11/02/1998
Decision Date
03/15/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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