HYGOFLEX SALIVA-EJECTOR— 510(k) K935758

Substantially Equivalent

J.H.Orsing AB

FDA 510(k) clearance K935758 for HYGOFLEX SALIVA-EJECTOR, Substantially Equivalent on 1994-03-21. Applicant: J.H.Orsing AB. Device class: 1.

Clearance details

Applicant: J.H.Orsing AB
Product code: Code DYN
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1993-11-26
Decision date: 1994-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raa, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYN

K940769 — DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR1994-08-17
K935616 — SALIVA EJECTOR DISPOSABLE1994-03-21
K924211 — EJECTOR1993-03-31
K920492 — HIGH VAC1992-05-11
K921117 — MINIDAM1992-05-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.