DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE— 510(k) K962545

Name: FDA 510(k) clearance K962545
Creator: U.S. Food and Drug Administration
Published: 1997-03-07

Substantially Equivalent

Sterilization Cassette Systems, Inc.

FDA 510(k) clearance K962545 for DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE, Substantially Equivalent on 1997-03-07. Applicant: Sterilization Cassette Systems, Inc.. Device class: 2.

Clearance details

Applicant: Sterilization Cassette Systems, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1996-06-28
Decision date: 1997-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood, IN, US

Download summary PDF View on FDA.gov ↗

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K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03

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