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510(k) K060471

FSSB NYLON SURGICAL SUTURES by Fssb Chirurgische Nadeln GmbH — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2006
Date Received
February 23, 2006
Clearance Type
Abbreviated
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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  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (February 17, 2016)
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  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)
  • K053637 — MANI NEEDLE & SUTURE PACK (NYLON) (May 19, 2006)