Cleared Traditional

COLOR-EZE PRE-WASHED LAP SPONGES

K831913 · Ormed Mfg., Inc. · General & Plastic Surgery

Sep 1983

Decision

104d

Days

Class 1

Risk

About This 510(k) Submission

K831913 is an FDA 510(k) clearance for the COLOR-EZE PRE-WASHED LAP SPONGES, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by Ormed Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983, 104 days after receiving the submission on June 14, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.

Submission Details

510(k) Number	K831913 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 1983
Decision Date	September 26, 1983
Days to Decision	104 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—