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510(k) K965162

LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. by Lukens Medical Corp. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1997
Date Received
December 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

Other clearances by Lukens Medical Corp.

  • K930944 — LUKENS SURGICAL GUT SUTURE (December 17, 1993)
  • K930943 — LUKENS NYLON SURGICAL SUTURE (December 17, 1993)
  • K930942 — LUKENS SILK SURGICAL SUTURE (December 17, 1993)
  • K930941 — LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE (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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