Cleared Traditional

MED-TEC TESTICULAR SEPARATOR

K951679 · Medtec, Inc. · Radiology
Jul 1995
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K951679 is an FDA 510(k) clearance for the MED-TEC TESTICULAR SEPARATOR, 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 12, 1995, 92 days after receiving the submission on April 11, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K951679 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1995
Decision Date July 12, 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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