Cleared Traditional

CAST SHOE, CAST BOOT

K830246 · Warm & Form, Orthopedic Materials · Chemistry
Feb 1983
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K830246 is an FDA 510(k) clearance for the CAST SHOE, CAST BOOT, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Warm & Form, Orthopedic Materials (Mchenry, US). The FDA issued a Cleared decision on February 18, 1983, 24 days after receiving the submission on January 25, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K830246 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1983
Decision Date February 18, 1983
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQB — Kinetic Method, Gamma-glutamyl Transpeptidase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1360

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