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FDA 510(k) Application Details - K163245
Device Classification Name
System, Optical Position/Movement Recording
More FDA Info for this Device
510(K) Number
K163245
Device Name
System, Optical Position/Movement Recording
Applicant
Barron Associates, Inc.
1410 Sachem Place
Suite 202
Charlottesville, VA 22901 US
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Contact
Bruce G. Wilson
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LXJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2016
Decision Date
02/28/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K163245
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