ControlRad Sterile Cover— 510(k) K200238

Substantially Equivalent

Controlrad, Inc.

FDA 510(k) clearance K200238 for ControlRad Sterile Cover, Substantially Equivalent on 2020-04-26. Applicant: Controlrad, Inc.. Device class: 2.

Clearance details

Applicant: Controlrad, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2020-01-31
Decision date: 2020-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

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More clearances from Controlrad, Inc.

K213455 — ControlRad Select Model Z2021-11-24
K211782 — ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 92021-07-01
K202431 — ControlRad Select Model Z2020-12-23
K200663 — ControlRad Trace Model 92020-06-24
K183109 — ControlRad Trace Model 82019-05-13

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