FDA 510(k) Application Details - K172882

Device Classification Name System, Optical Position/Movement Recording

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510(K) Number K172882
Device Name System, Optical Position/Movement Recording
Applicant UINCARE Corp.
A-603, 131, Gasan digital 1-ro
Geumcheon-gu 08506 KR
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Contact Youngbean You
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Regulation Number 000.0000

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Classification Product Code LXJ
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Date Received 09/21/2017
Decision Date 05/10/2018
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 K172882


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