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FDA 510(k) Application Details - K003777
Device Classification Name
Clip, Implantable
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4300
More FDA Info for this Regulation Number
Classification Product Code
FZP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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