Cleared Traditional

AGEE-WRISTJACK PRE-DRILL KIT

K942906 · Hand Biomechanics Lab, Inc. · Orthopedic
Dec 1994
Decision
184d
Days
Class 1
Risk

About This 510(k) Submission

K942906 is an FDA 510(k) clearance for the AGEE-WRISTJACK PRE-DRILL KIT, a Bit, Drill (Class I — General Controls, product code HTW), submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on December 22, 1994, 184 days after receiving the submission on June 21, 1994. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K942906 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1994
Decision Date December 22, 1994
Days to Decision 184 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code HTW — Bit, Drill
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540