Cleared Traditional

DRILL, HAND, BONE, SMEDBERG

K871834 · Military Engineering, Inc. · Dental
Jul 1987
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K871834 is an FDA 510(k) clearance for the DRILL, HAND, BONE, SMEDBERG, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 31, 1987, 80 days after receiving the submission on May 12, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K871834 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1987
Decision Date July 31, 1987
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZJ — Driver, Wire, And Bone Drill, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120