Cleared Traditional

EMC MODEL NO. STATOME 900

K911353 · Emc Industries · General & Plastic Surgery

Jun 1991

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K911353 is an FDA 510(k) clearance for the EMC MODEL NO. STATOME 900, a Apparatus, Electrosurgical (Class II — Special Controls, product code HAM), submitted by Emc Industries (Los Altos, US). The FDA issued a Cleared decision on June 24, 1991, 89 days after receiving the submission on March 27, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K911353 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 1991
Decision Date	June 24, 1991
Days to Decision	89 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—