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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K041331
Device Name BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
Applicant
BIOPSY SCIENCES, LLC
5582 CHALON RD.
YORBA LINDA,  CA  92886
Applicant Contact SHARON ROCKWELL
Correspondent
BIOPSY SCIENCES, LLC
5582 CHALON RD.
YORBA LINDA,  CA  92886
Correspondent Contact SHARON ROCKWELL
Regulation Number878.4750
Classification Product Code
GDW  
Date Received05/19/2004
Decision Date 06/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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