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510(k) K042286

UNIESTER C by United Medical Industries Co. , Ltd. — Product Code GAT

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, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by United Medical Industries Co. , Ltd.

  • K072646 — UNICAPRONE (November 7, 2007)
  • K072645 — UNIGLACTIN (November 7, 2007)
  • K072644 — UNICRYL QUICK (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)
  • K042283 — UNIPRO (December 1, 2004)
  • K042282 — UNISILK (December 1, 2004)

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  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
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