Cleared Traditional

STERILE O. R. TOWEL

K861928 · Anago, Inc. · Radiology
Jun 1986
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K861928 is an FDA 510(k) clearance for the STERILE O. R. TOWEL, a Processor, Cine Film (Class II — Special Controls, product code IXX), submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on June 9, 1986, 20 days after receiving the submission on May 20, 1986. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number K861928 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1986
Decision Date June 09, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IXX — Processor, Cine Film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1900