Cleared Traditional

GENERAL SURGERY CLAMP AND NEEDLE HOLDER

K922659 · Miltex Instrument Co. · General & Plastic Surgery

Jul 1992

Decision

48d

Days

Class 1

Risk

About This 510(k) Submission

K922659 is an FDA 510(k) clearance for the GENERAL SURGERY CLAMP AND NEEDLE HOLDER, a Clamp, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDJ), submitted by Miltex Instrument Co. (Lake Success, US). The FDA issued a Cleared decision on July 21, 1992, 48 days after receiving the submission on June 3, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K922659 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 1992
Decision Date	July 21, 1992
Days to Decision	48 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement