Cleared Traditional

7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1

K851751 · Artiberia · General & Plastic Surgery

Jun 1985

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K851751 is an FDA 510(k) clearance for the 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1, a Scalpel, One-piece (Class I — General Controls, product code GDX), submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 20, 1985, 56 days after receiving the submission on April 25, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K851751 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 1985
Decision Date	June 20, 1985
Days to Decision	56 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—