AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM— 510(k) K982088

Name: FDA 510(k) clearance K982088
Creator: U.S. Food and Drug Administration
Published: 1998-09-04

Substantially Equivalent

Ortho Kinetics Corp.

FDA 510(k) clearance K982088 for AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM, Substantially Equivalent on 1998-09-04. Applicant: Ortho Kinetics Corp.. Device class: 2.

Clearance details

Applicant: Ortho Kinetics Corp.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 1998-06-15
Decision date: 1998-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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