Cleared Traditional

VALTRAC (BAR) REMOVER DEVICE

K863752 · Davis & Geck, Inc. · General & Plastic Surgery
Oct 1986
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K863752 is an FDA 510(k) clearance for the VALTRAC (BAR) REMOVER DEVICE, a Knife, Surgical (Class I — General Controls, product code EMF), submitted by Davis & Geck, Inc. (Danbury, US). The FDA issued a Cleared decision on October 24, 1986, 29 days after receiving the submission on September 25, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K863752 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1986
Decision Date October 24, 1986
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code EMF — Knife, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800