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510(k) K863034

SHARPOINT STAINLESS STEEL SUTURE by Chathamborough Research Group, Inc. — Product Code GAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1986
Date Received
August 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type

Other clearances by Chathamborough Research Group, Inc.

  • K915676 — SPLATTER SHIELD (September 11, 1992)
  • K904906 — SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP (December 24, 1990)
  • K902309 — PARKER MICROPUMP MODEL 2100 (August 17, 1990)

Other clearances for product code GAO

  • K932513 — LABELING FOR MYO/WIRE II STERNOTOMY SUTURES (January 7, 1994)
  • K872532 — AUTO SUTURE STAINLESS STEEL SUTURES* (August 5, 1987)
  • K802248 — DISARP ORIGINAL (September 26, 1980)