FDA 510(k) Application Details - K060163

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K060163
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant PETERS SURGICAL
Z.I. LES VIGNES
42 RUE BENOIT FRACHON
BOBIGNY 93013 FR
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Contact ANNIE LASSERRE
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 01/23/2006
Decision Date 10/11/2006
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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