MRI Fastsystem Retractor System

FDA 510(k) K001339 · Omni-Tract Surgical, Div. Minn. Scientific, Inc.

Substantially Equivalent

510(k) numberK001339

Submission

Device name
MRI Fastsystem Retractor System
Applicant
Omni-Tract Surgical, Div. Minn. Scientific, Inc.
Minneapolis, MN, US
Received
April 27, 2000
Decision date
May 17, 2000
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GAD – Retractor
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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Questions and answers

When was MRI Fastsystem Retractor System cleared by the FDA?

MRI Fastsystem Retractor System (K001339) received a 510(k) decision of Substantially Equivalent on May 17, 2000, 20 days after the submission was received.

What is the product code of K001339?

The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.