FDA 510(k) Application Details - K092533

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K092533
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF
5307 95TH AVE.
KENOSHA, WI 53144 US
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Contact JOY VOIGT
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 08/19/2009
Decision Date 09/15/2009
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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