FDA 510(k) Application Details - K023125

Device Classification Name Suture, Nonabsorbable, Nitinol

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510(K) Number K023125
Device Name Suture, Nonabsorbable, Nitinol
Applicant COALESCENT SURGICAL
559 EAST WEDDELL DR.
SUNNYVALE, CA 94089 US
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Contact MICHAEL A DANIEL
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Regulation Number 878.4495

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Classification Product Code NJU
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Date Received 09/19/2002
Decision Date 12/18/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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