Cleared Traditional

DRESSING CHANGE TRAY STERILE 5002

K842404 · Pro-Lab, Inc. · General & Plastic Surgery

Dec 1984

Decision

168d

Days

—

Risk

About This 510(k) Submission

K842404 is an FDA 510(k) clearance for the DRESSING CHANGE TRAY STERILE 5002, submitted by Pro-Lab, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1984, 168 days after receiving the submission on June 19, 1984. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K842404 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 1984
Decision Date	December 04, 1984
Days to Decision	168 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—