FDA 510(k) Application Details - K042856

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K042856
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING, PA 19606 US
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Contact ELIZABETH LAZARO
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 10/04/2004
Decision Date 12/03/2004
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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