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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K003777
Device Name CARIS SITE MARKER
Applicant
ARTEMIS MEDICAL, INC.
655 MARINERS ISLAND BLVD.
SUITE 303
SAN MATEO,  CA  94404
Applicant Contact ROBIN BUSH
Correspondent
ARTEMIS MEDICAL, INC.
655 MARINERS ISLAND BLVD.
SUITE 303
SAN MATEO,  CA  94404
Correspondent Contact ROBIN BUSH
Regulation Number878.4300
Classification Product Code
FZP  
Date Received12/07/2000
Decision Date 03/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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