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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 K001807
Device Name TISSUE MARKER
Applicant
Advanced Uroscience, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact KAREN E PETERSON
Correspondent
Advanced Uroscience, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact KAREN E PETERSON
Regulation Number878.4750
Classification Product Code
GDW  
Date Received06/15/2000
Decision Date 05/03/2001
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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