Cleared Traditional

CARAPACE STERILE CAST PADDING

K931672 · Carapace, Inc. · Orthopedic
Dec 1993
Decision
253d
Days
Class 1
Risk

About This 510(k) Submission

K931672 is an FDA 510(k) clearance for the CARAPACE STERILE CAST PADDING, a Component, Cast (Class I — General Controls, product code LGF), submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on December 15, 1993, 253 days after receiving the submission on April 6, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.5940.

Submission Details

510(k) Number K931672 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1993
Decision Date December 15, 1993
Days to Decision 253 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