Cleared Traditional

WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

K000768 · Wallach Surgical Devices, Inc. · Dental
Apr 2000
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K000768 is an FDA 510(k) clearance for the WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR, a Unit, Electrosurgical, And Accessories, Dental (Class II — Special Controls, product code EKZ), submitted by Wallach Surgical Devices, Inc. (Orange, US). The FDA issued a Cleared decision on April 11, 2000, 33 days after receiving the submission on March 9, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.4920.

Submission Details

510(k) Number K000768 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2000
Decision Date April 11, 2000
Days to Decision 33 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EKZ — Unit, Electrosurgical, And Accessories, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4920