Cleared Traditional

TRAY DOUGH

K911225 · The Hygenic Corp. · General & Plastic Surgery
Apr 1991
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K911225 is an FDA 510(k) clearance for the TRAY DOUGH, a Retention Device, Suture (Class I — General Controls, product code KGS), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on April 17, 1991, 27 days after receiving the submission on March 21, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4930.

Submission Details

510(k) Number K911225 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1991
Decision Date April 17, 1991
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KGS — Retention Device, Suture
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4930