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510(k) K031292

MODIFICATION TO FOSSA URETERAL STONE SWEEPER by Fossa Medical, Inc. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2003
Date Received
April 23, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

Other clearances by Fossa Medical, Inc.

  • K072293 — FOSSA URETERAL OPEN STENTS (August 6, 2008)
  • K033368 — FOSSA URETERAL OPEN LUMEN STENT (November 26, 2003)

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