Cleared Traditional

ALGINATE WOOL FIBER

K870383 · Adri · Dental
Apr 1987
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K870383 is an FDA 510(k) clearance for the ALGINATE WOOL FIBER, a Absorber, Saliva, Paper (Class I — General Controls, product code KHR), submitted by Adri (Park Forest, US). The FDA issued a Cleared decision on April 30, 1987, 90 days after receiving the submission on January 30, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number K870383 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1987
Decision Date April 30, 1987
Days to Decision 90 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