FDA 510(k) Application Details - K141072

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K141072
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant RESORBA MEDICAL GMBH
AM FLACHMOOOR 16
NUREMBERG 90475 DE
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Contact KARL-JOSEF BECK
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 04/25/2014
Decision Date 06/23/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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