FDA 510(k) Application Details - K170272

Device Classification Name Plate, Bone

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510(K) Number K170272
Device Name Plate, Bone
Applicant Materialise NV
Technologielaan 15
Leuven 3001 BE
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Contact Lina Ramirez
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 01/30/2017
Decision Date 08/08/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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