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FDA 510(k) Application Details - K032217
Device Classification Name
Clip, Implantable
More FDA Info for this Device
510(K) Number
K032217
Device Name
Clip, Implantable
Applicant
ARTEMIS MEDICAL, INC.
21021 CORSAIR BLVD.
HAYWARD, CA 94545 US
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LINDA GUTHRIE
Other 510(k) Applications for this Contact
Regulation Number
878.4300
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Classification Product Code
FZP
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More FDA Info for this Product Code
Date Received
07/21/2003
Decision Date
08/21/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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