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510(k) K001807

TISSUE MARKER by Advanced Uroscience, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2001
Date Received
June 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Advanced Uroscience, Inc.

  • K002573 — ADVANCED UROSCIENCE INNERSHEATH (November 16, 2000)
  • K002323 — ADVANCED UROSCIENCE INJECTION NEEDLE (July 31, 2000)
  • K993459 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (November 5, 1999)
  • K982890 — ADVANCED UROSCIENCE INJECTION NEEDLE (October 26, 1998)

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