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510(k) K930941

LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE by Lukens Medical Corp. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1993
Date Received
February 23, 1993
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 Lukens Medical Corp.

  • K965162 — LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRA (February 12, 1997)
  • K930944 — LUKENS SURGICAL GUT SUTURE (December 17, 1993)
  • K930942 — LUKENS SILK SURGICAL SUTURE (December 17, 1993)
  • K930943 — LUKENS NYLON SURGICAL SUTURE (December 17, 1993)
  • K930945 — BRAIDED POLYESTER SURGICAL SUTURE (December 17, 1993)
  • K930940 — LUKENS STAINLESS STEEL SURGICAL SUTURE (December 17, 1993)
  • K904535 — LU-TEX II (January 30, 1991)

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  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)
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