PMT External External Drainage System (Eds)

Q: What is the product code of K935560?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.

FDA 510(k) K935560 · Pmt Corp.

Substantially Equivalent

510(k) numberK935560

Submission

Device name: PMT External External Drainage System (Eds)
Applicant: Pmt Corp.
Chanhassen, MN, US
Received: November 17, 1993
Decision date: November 7, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: JXG – Shunt, Central Nervous System And Components
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5550
Specialty: Neurology
Implant: Yes

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Questions and answers

When was PMT External External Drainage System (Eds) cleared by the FDA?

PMT External External Drainage System (Eds) (K935560) received a 510(k) decision of Substantially Equivalent on November 7, 1994, 355 days after the submission was received.

What is the product code of K935560?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.