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510(k) K931916

SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER by Surgimetrics International, Ltd. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1994
Date Received
April 16, 1993
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 Surgimetrics International, Ltd.

  • K931914 — SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE (October 5, 1994)
  • K931913 — SUTURE NON-ABSORBABLE SILK (March 3, 1994)
  • K931918 — CATGUT SUTURE PLAIN (March 3, 1994)
  • K931917 — SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE (March 3, 1994)
  • K931915 — STAINLESS STEEL SUTURE (March 3, 1994)
  • K931919 — CATGUT SUTURE CHROMIC (March 3, 1994)

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