Cleared Traditional

MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM

K943346 · Patton, Boggs & Blow · Dental
Oct 1994
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K943346 is an FDA 510(k) clearance for the MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Patton, Boggs & Blow (Washington, US). The FDA issued a Cleared decision on October 4, 1994, 84 days after receiving the submission on July 12, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K943346 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 1994
Decision Date October 04, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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