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510(k) K040163

MICROVASCULAR ANASTOMOTIC DEVICE by Synovis Micro Companies Alliance, Inc. — Product Code MVR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2004
Date Received
January 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anastomotic, Microvascular
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

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  • K093310 — GEM FLOW COUPLER DEVICE AND SYSTEM (February 1, 2010)

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  • K142309 — GEM Flow COUPLER Device and System (September 16, 2014)
  • K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM (October 22, 2013)
  • K093310 — GEM FLOW COUPLER DEVICE AND SYSTEM (February 1, 2010)
  • K090679 — VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM (April 17, 2009)
  • K861985 — 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) (December 4, 1986)