FDA 510(k) Application Details - K962377

Device Classification Name Goniometer, Ac-Powered

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510(K) Number K962377
Device Name Goniometer, Ac-Powered
Applicant SKILL TECHNOLOGIES, INC.
1202 EAST MARYLAND AVE.,
SUITE 1G
PHOENIX, AZ 85014 US
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Regulation Number 888.1500

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Classification Product Code KQX
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Date Received 06/20/1996
Decision Date 09/03/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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