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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 K032217
Device Name 14G CORMARK BIOPSY SITE IDENTIFIER
Applicant
Artemis Medical, Inc.
21021 Corsair Blvd.
Haywayd,  CA  94545
Applicant Contact LINDA GUTHRIE
Correspondent
Artemis Medical, Inc.
21021 Corsair Blvd.
Haywayd,  CA  94545
Correspondent Contact LINDA GUTHRIE
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
NEU  
Date Received07/21/2003
Decision Date 08/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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