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510(k) K152795

RiverLon (Nylon) Suture by Riverpoint Medical — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2015
Date Received
September 28, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type

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  • K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (May 28, 2013)
  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)
  • K060471 — FSSB NYLON SURGICAL SUTURES (July 26, 2006)
  • K053637 — MANI NEEDLE & SUTURE PACK (NYLON) (May 19, 2006)