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510(k) K172545

SERI Contour by Sofregen Medical, Inc. — Product Code OXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2017
Date Received
August 23, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.

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  • K163217 — GORE BIO-A Tissue Reinforcement (February 10, 2017)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)