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510(k) K802006

TRIANGULAR BANDAGE CAT.#191 by Pollak (Intl.), Ltd. — Product Code ILI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sling, Arm
Device Class
Class I
Regulation Number
890.3640
Review Panel
PM
Submission Type

Other clearances by Pollak (Intl.), Ltd.

  • K000227 — UMBICUT (April 27, 2000)
  • K810049 — PEDICAT* (April 21, 1981)
  • K810050 — VECAFIX* (March 26, 1981)
  • K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 (October 31, 1980)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)
  • K802017 — DRESSING CHANGE SET CAT.#910-930 (October 10, 1980)
  • K802007 — PEDIWET=GUAZE IMPREGNATED WITH PETROL (September 26, 1980)
  • K801996 — GUAZE BANDAGES CAT.#101-169 (September 16, 1980)
  • K802004 — PROFILE SWAB CAT.#5273 & 5274 (September 16, 1980)
  • K802021 — PEDIBAND CAT.#195-197 (September 16, 1980)

Other clearances for product code ILI

  • K912661 — MATRX, PYRAMID TRIANGLE BANDAGE (August 21, 1991)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831706 — SATO FAMILY FIRST AID KIT (June 24, 1983)
  • K823810 — A.C. SPLINT (January 14, 1983)
  • K823808 — VARIOUS ARM SLING (January 14, 1983)
  • K823664 — UNIVERSAL SLING, SLING & SWATHE (December 30, 1982)
  • K823162 — UNIVERSAL SLING, SLING & SWATHE (November 10, 1982)
  • K820590 — ORTHOPEDIC SOFT GOODS (March 26, 1982)
  • K812480 — LIMB HOLDER ARM SLING (September 14, 1981)
  • K812478 — MADDACOMFORT SLING (September 14, 1981)