Cleared Traditional

MATRX, PYRAMID TRIANGLE BANDAGE

K912661 · Matrix Medica, Inc. · Physical Medicine
Aug 1991
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K912661 is an FDA 510(k) clearance for the MATRX, PYRAMID TRIANGLE BANDAGE, a Sling, Arm (Class I — General Controls, product code ILI), submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on August 21, 1991, 64 days after receiving the submission on June 18, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3640.

Submission Details

510(k) Number K912661 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1991
Decision Date August 21, 1991
Days to Decision 64 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ILI — Sling, Arm
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3640