Cleared Traditional

MICROTENS 7757 T.E.N.S. STIMULATOR

K844017 · Rabar, Inc. · General & Plastic Surgery

Nov 1984

Decision

46d

Days

Class 1

Risk

About This 510(k) Submission

K844017 is an FDA 510(k) clearance for the MICROTENS 7757 T.E.N.S. STIMULATOR, a Mallet, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFJ), submitted by Rabar, Inc. (Rochester, US). The FDA issued a Cleared decision on November 30, 1984, 46 days after receiving the submission on October 15, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K844017 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 1984
Decision Date	November 30, 1984
Days to Decision	46 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—