Cleared Traditional

PAINTED WEDGE & ROD BREAST BOARD

K952729 · Medtec, Inc. · Radiology
Sep 1995
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K952729 is an FDA 510(k) clearance for the PAINTED WEDGE & ROD BREAST BOARD, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on September 15, 1995, 92 days after receiving the submission on June 15, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K952729 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1995
Decision Date September 15, 1995
Days to Decision 92 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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