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510(k) K912661

MATRX, PYRAMID TRIANGLE BANDAGE by Matrix Medica, Inc. — Product Code ILI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1991
Date Received
June 18, 1991
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

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  • K895525 — MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER (January 26, 1990)
  • K895533 — LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER (January 26, 1990)
  • K893219 — MATRX DENTAL UNIT (August 7, 1989)
  • K883833 — NITRONOX(R), FIRST RESPONSE NITRONOX(TM) (February 17, 1989)
  • K884879 — CENTURION(TM) MIXER (February 9, 1989)

Other clearances for product code ILI

  • 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)
  • K812477 — ARM SLING, POUCH TYPE (September 14, 1981)