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510(k) K926127

SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM by Life Medical Sciences, Inc. — Product Code GAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1993
Date Received
December 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stapler, Surgical
Device Class
Class II
Regulation Number
878.4740
Review Panel
SU
Submission Type

A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Other clearances by Life Medical Sciences, Inc.

  • K980563 — SKAR-KARE SHEET (May 20, 1998)
  • K942526 — SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM (July 19, 1994)

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  • K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (April 8, 2022)