FDA 510(k) Application Details - K060465

Device Classification Name Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)

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510(K) Number K060465
Device Name Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
Applicant PETERS SURGICAL
42 RUE BENOIT FRACHON
Z.I. LES VIGNES
BOBIGNY 93013 FR
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Contact ANNIE LASSERRE
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Regulation Number 878.5010

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Classification Product Code MXW
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Date Received 02/22/2006
Decision Date 01/17/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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