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510(k) K042283

UNIPRO by United Medical Industries Co. , Ltd. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2004
Date Received
August 24, 2004
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 United Medical Industries Co. , Ltd.

  • K072645 — UNIGLACTIN (November 7, 2007)
  • K072644 — UNICRYL QUICK (November 7, 2007)
  • K072646 — UNICAPRONE (November 7, 2007)
  • K042287 — UNIPLAIN & UNICHROM (September 7, 2005)
  • K042288 — UNICRYL (December 27, 2004)
  • K042285 — UNICRYL M (December 10, 2004)
  • K042284 — UNIMIDE (December 3, 2004)
  • K042282 — UNISILK (December 1, 2004)
  • K042286 — UNIESTER C (December 1, 2004)

Other clearances for product code GAW

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  • 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)