Cleared Traditional

ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER

K021124 · Wfr/Aquaplast Corp. · Radiology
Jul 2002
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K021124 is an FDA 510(k) clearance for the ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Wfr/Aquaplast Corp. (Wyckoff, US). The FDA issued a Cleared decision on July 2, 2002, 85 days after receiving the submission on April 8, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K021124 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2002
Decision Date July 02, 2002
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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