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510(k) K943220

SUTULENE by Sutures , Ltd. — Product Code GAT

Clearance Details

Decision
SN ()
Decision Date
December 5, 1994
Date Received
July 5, 1994
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 Sutures , Ltd.

  • K990432 — SURGISORB (May 27, 1999)
  • K953609 — PRODEK (January 31, 1996)
  • 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)
  • K943216 — SURGIDEK (December 5, 1994)
  • K943222 — SURGIDEK S (December 5, 1994)
  • K865038 — SURGISTEEL (June 30, 1987)

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