Cleared Traditional

PROTEC COTTON PADDING BANDAGE

K955320 · Derivadas Degasa S.A. DE C.V. · Orthopedic
Jan 1996
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K955320 is an FDA 510(k) clearance for the PROTEC COTTON PADDING BANDAGE, a Component, Cast (Class I — General Controls, product code LGF), submitted by Derivadas Degasa S.A. DE C.V. (Palm Harobor, US). The FDA issued a Cleared decision on January 26, 1996, 67 days after receiving the submission on November 20, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.5940.

Submission Details

510(k) Number K955320 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1995
Decision Date January 26, 1996
Days to Decision 67 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code LGF — Component, Cast
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.5940