FDA 510(k) Application Details - K020940

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K020940
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant SUTURA, INC.
17080 NEWHOPE ST.
FOUNTAIN VALLEY, CA 92708 US
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Contact JAMES BONDS
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 03/22/2002
Decision Date 04/17/2002
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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