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510(k) K993997

POLYPROPYLENE by Trading Consultants and Distributors Intl., Inc. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2000
Date Received
November 24, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by Trading Consultants and Distributors Intl., Inc.

  • K994001 — POLYGLYCOLIC ACID (February 9, 2000)
  • K994002 — PLAIN/CHROMIC CATGUT (February 4, 2000)
  • K993999 — SILK (February 4, 2000)
  • K993998 — NYLON (February 4, 2000)
  • K994000 — POLYESTER (February 4, 2000)

Other clearances for product code GAW

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  • K230746 — Non absorbable Surgical Polypropylene Suture (September 14, 2023)
  • K221280 — Vesseal (December 9, 2022)
  • K211178 — DURAMESH Mesh Suture (September 2, 2022)
  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)
  • K173644 — Gazelle Polypropylene Suture and Delivery Device (February 15, 2018)