FDA 510(k) Application Details - K032980

Device Classification Name Clip, Implantable

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510(K) Number K032980
Device Name Clip, Implantable
Applicant VANGUARD MEDICAL CONCEPTS, INC.
3706 76TH STREET
LUBBOCK, TX 79423 US
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Contact MARK ALDANA
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 09/24/2003
Decision Date 12/18/2003
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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