Cleared Traditional

HYGOFLEX SALIVA-EJECTOR

K935758 · J.H.Orsing AB · Dental
Mar 1994
Decision
115d
Days
Class 1
Risk

About This 510(k) Submission

K935758 is an FDA 510(k) clearance for the HYGOFLEX SALIVA-EJECTOR, a Mouthpiece, Saliva Ejector (Class I — General Controls, product code DYN), submitted by J.H.Orsing AB (Raa, SE). The FDA issued a Cleared decision on March 21, 1994, 115 days after receiving the submission on November 26, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K935758 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1993
Decision Date March 21, 1994
Days to Decision 115 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DYN — Mouthpiece, Saliva Ejector
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640