Cleared Traditional

K900376 - HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)
(FDA 510(k) Clearance)

K900376 · Pmt Corp. · General & Plastic Surgery

Apr 1990

Decision

74d

Days

Class 1

Risk

K900376 is an FDA 510(k) clearance for the HAND SURGERY AND IRRIGATION TRAY (MODEL 3625), a Tray, Surgical, Instrument (Class I — General Controls, product code FSM), submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on April 10, 1990, 74 days after receiving the submission on January 26, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K900376 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 1990
Decision Date	April 10, 1990
Days to Decision	74 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—