Cleared Traditional

MED-TEC REDI-FOAM

K951808 · Medtec, Inc. · Radiology
Jul 1995
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K951808 is an FDA 510(k) clearance for the MED-TEC REDI-FOAM, 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 July 6, 1995, 78 days after receiving the submission on April 19, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K951808 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1995
Decision Date July 06, 1995
Days to Decision 78 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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