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FDA 510(k) Application Details - K132104
Device Classification Name
Intraoperative Orthopedic Joint Assessment Aid
More FDA Info for this Device
510(K) Number
K132104
Device Name
Intraoperative Orthopedic Joint Assessment Aid
Applicant
Kamm & Associates
8870 RAVELLO CT
NAPLES, FL 34114 US
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Contact
DANIEL KAMM, P.E.
Other 510(k) Applications for this Contact
Regulation Number
882.4560
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Classification Product Code
ONN
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More FDA Info for this Product Code
Date Received
07/08/2013
Decision Date
03/21/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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