Cleared Traditional

CUSTOM OPEN HEART TRAY

K850072 · Pro-Lab, Inc. · General & Plastic Surgery

Mar 1985

Decision

65d

Days

—

Risk

About This 510(k) Submission

K850072 is an FDA 510(k) clearance for the CUSTOM OPEN HEART TRAY, submitted by Pro-Lab, Inc. (Birmingham, US). The FDA issued a Cleared decision on March 15, 1985, 65 days after receiving the submission on January 9, 1985. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K850072 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 09, 1985
Decision Date	March 15, 1985
Days to Decision	65 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—