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510(k) K953609

PRODEK by Sutures , Ltd. — Product Code GAW

Clearance Details

Decision
SN ()
Decision Date
January 31, 1996
Date Received
August 2, 1995
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 Sutures , Ltd.

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  • K943220 — SUTULENE (December 5, 1994)
  • K943216 — SURGIDEK (December 5, 1994)
  • K943217 — PLAIN CATGUT (December 5, 1994)
  • K943627 — SURGISILK (December 5, 1994)
  • K943223 — SURGIDEK B (December 5, 1994)
  • K943218 — CHROMIC CATGUT (December 5, 1994)
  • K943221 — SURGIBOND (December 5, 1994)
  • K943222 — SURGIDEK S (December 5, 1994)
  • K865038 — SURGISTEEL (June 30, 1987)

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  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
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  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)
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