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510(k) K053300

SYVEKEXCEL by Marine Polymer Technologies, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2006
Date Received
November 25, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Other clearances by Marine Polymer Technologies, Inc.

  • K160695 — Talymed Suspension (December 6, 2016)
  • K132293 — SYVEK RADIAL BAND (July 31, 2014)
  • K111524 — MP 719 (July 22, 2011)
  • K102002 — TALYMED (July 28, 2010)
  • K082703 — MRDH BANDAGE (October 14, 2008)
  • K070557 — MP 719 (May 23, 2007)
  • K002550 — RDH BANDAGE (December 20, 2000)
  • K984177 — MODIFICATION TO SKVEKPATCH (December 18, 1998)
  • K972914 — SYVEK PATCH (December 22, 1997)

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