FDA 510(k) Application Details - K003777

Device Classification Name Clip, Implantable

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510(K) Number K003777
Device Name Clip, Implantable
Applicant ARTEMIS MEDICAL, INC.
655 MARINERS ISLAND BLVD.
SUITE 303
SAN MATEO, CA 94404 US
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Contact ROBIN BUSH
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 12/07/2000
Decision Date 03/06/2001
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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