Cleared Traditional

K874050 - INFLATABLE FOOT & ANKLE SPLINT
(FDA 510(k) Clearance)

K874050 · Vinyl Technology, Inc. · General & Plastic Surgery
Nov 1987
Decision
49d
Days
Class 1
Risk

K874050 is an FDA 510(k) clearance for the INFLATABLE FOOT & ANKLE SPLINT, a Splint, Extremity, Inflatable, External (Class I — General Controls, product code FZF), submitted by Vinyl Technology, Inc. (So. El Monte, US). The FDA issued a Cleared decision on November 23, 1987, 49 days after receiving the submission on October 5, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3900.

Submission Details

510(k) Number K874050 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1987
Decision Date November 23, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZF — Splint, Extremity, Inflatable, External
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.3900