FDA 510(k) Application Details - K130580

Device Classification Name Cord, Retraction

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510(K) Number K130580
Device Name Cord, Retraction
Applicant DMG USA, INC.
5 WHITCOMB AVE.
AYER, MA 01432 US
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Contact PAMELA PAPINEAU, RAC
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Regulation Number 000.0000

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Classification Product Code MVL
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Date Received 03/05/2013
Decision Date 02/25/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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