RENDER-PLAN 3-D— 510(k) K992864

Substantially Equivalent

Precision Therapy Intl., Inc.

FDA 510(k) clearance K992864 for RENDER-PLAN 3-D, Substantially Equivalent on 1999-09-09. Applicant: Precision Therapy Intl., Inc.. Device class: 2.

Clearance details

Applicant: Precision Therapy Intl., Inc.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1999-08-25
Decision date: 1999-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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