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510(k) K802248

DISARP ORIGINAL by Unoplast A/S — Product Code GAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
September 16, 1980
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 Unoplast A/S

  • K896734 — FEEDING TUBE (December 21, 1990)
  • K896729 — NELATON-, FEMALE - OR TIEMANN CATHETER (November 5, 1990)
  • K896732 — UNOMETER 500 (November 2, 1990)
  • K896730 — SUCTION CATHETER STRAIGHT/COUDE (March 30, 1990)
  • K896731 — OXYGEN CATHETERS (March 30, 1990)
  • K896733 — VACCON (February 1, 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)
  • K863034 — SHARPOINT STAINLESS STEEL SUTURE (September 30, 1986)