VSP SYSTEM— 510(k) K133907

Substantially Equivalent

Medical Modeling, Inc.

FDA 510(k) clearance K133907 for VSP SYSTEM, Substantially Equivalent on 2014-01-22. Applicant: Medical Modeling, Inc.. Device class: 2.

Clearance details

Applicant: Medical Modeling, Inc.
Product code: Code DZJ
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2013-12-23
Decision date: 2014-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medical Modeling, Inc.

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Recalls naming K133907

K-number listed on FDA's recall record

Z-1510-2022 — 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-SterileClass II·Ongoing·Medical Modeling, Inc.·20220517

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133907.

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