FDA 510(k) Application Details - K172937

Device Classification Name Mesh, Surgical

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510(K) Number K172937
Device Name Mesh, Surgical
Applicant Colorado Therapeutics LLC
2150 West 6th Avenue, Suite L
Bloomfield, CA 80020 US
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Contact William Jackson
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 09/26/2017
Decision Date 10/25/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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