ERGO IRRIGATION SYSTEM— 510(k) K802595

Substantially Equivalent

Ergo Instruments, Inc.

FDA 510(k) clearance K802595 for ERGO IRRIGATION SYSTEM, Substantially Equivalent on 1980-11-12. Applicant: Ergo Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Ergo Instruments, Inc.
Product code: Code EFS
Device class: Class 1
Regulation: 21 CFR 872.6510
Advisory panel: Dental
Date received: 1980-10-21
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFS

K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE2002-12-11
K001493 — DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 00200012000-10-25
K983374 — AGATHA-A-H20101998-12-23
K964810 — DERMADAM1997-02-10
K952234 — BARRIER ALL FILM1995-07-31

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