FDA 510(k) Application Details - K041894

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K041894
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant CP MEDICAL
803 N.E. 25TH AVENUE
PORTLAND, OR 97232 US
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Contact MARY ANN GREENAWALT
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 07/13/2004
Decision Date 09/17/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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