FDA 510(k) Application Details - K040602

Device Classification Name Clip, Implantable

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510(K) Number K040602
Device Name Clip, Implantable
Applicant DESIGN STANDARDS CORP.
182 CEDA RD.
P.O. BOX 1620
CHARLESTOWN, NH 03603 US
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Contact MICHELE LUCEY
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 03/08/2004
Decision Date 05/10/2004
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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