AGATHA-A-H2010— 510(k) K983374

Substantially Equivalent

Midian Intl.

FDA 510(k) clearance K983374 for AGATHA-A-H2010, Substantially Equivalent on 1998-12-23. Applicant: Midian Intl.. Device class: 1.

Clearance details

Applicant: Midian Intl.
Product code: Code EFS
Device class: Class 1
Regulation: 21 CFR 872.6510
Advisory panel: Dental
Date received: 1998-09-25
Decision date: 1998-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lauderhill, FL, 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
K964810 — DERMADAM1997-02-10
K952234 — BARRIER ALL FILM1995-07-31
K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR1994-09-09

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