Cleared Traditional

NON-STERILE GAUZE SPONGE

K891054 · Dispomed, Inc. · Dental
May 1989
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K891054 is an FDA 510(k) clearance for the NON-STERILE GAUZE SPONGE, a Absorber, Saliva, Paper (Class I — General Controls, product code KHR), submitted by Dispomed, Inc. (Burbank, US). The FDA issued a Cleared decision on May 1, 1989, 63 days after receiving the submission on February 27, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number K891054 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1989
Decision Date May 01, 1989
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code KHR — Absorber, Saliva, Paper
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6050