Cleared Traditional

CONTROLLED TEMPERATURE CABINET SYSTEM

K973747 · Smith · General & Plastic Surgery

May 1998

Decision

218d

Days

—

Risk

About This 510(k) Submission

K973747 is an FDA 510(k) clearance for the CONTROLLED TEMPERATURE CABINET SYSTEM, submitted by Smith (Crofton, US). The FDA issued a Cleared decision on May 7, 1998, 218 days after receiving the submission on October 1, 1997. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K973747 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 1997
Decision Date	May 07, 1998
Days to Decision	218 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement