FDA 510(k) Application Details - K173893

Device Classification Name

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510(K) Number K173893
Device Name Trabis
Applicant coLigne, AG
Utoquai 43
Zurich CH 8008 CH
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Contact Robert Lange
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Regulation Number

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Classification Product Code PLR
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Date Received 12/21/2017
Decision Date 09/06/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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