FDA 510(k) Application Details - K060367

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K060367
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant FOURNITURES HOSPITALIERES INDUSTRIE
ZI DE KERNEVEZ-6 RUE NOBEL
QUIMPER 29000 FR
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Contact CHRISTINE QUENDEZ
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 02/13/2006
Decision Date 08/09/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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