Hydrocephalus Shunt System, Low/Medium/High Press.

FDA 510(k) K895524 · Theramed, Inc.

Substantially Equivalent

510(k) numberK895524

Submission

Device name
Hydrocephalus Shunt System, Low/Medium/High Press.
Applicant
Theramed, Inc.
Ft. Lauderdale, FL, US
Received
September 12, 1989
Decision date
April 10, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Hydrocephalus Shunt System, Low/Medium/High Press. cleared by the FDA?

Hydrocephalus Shunt System, Low/Medium/High Press. (K895524) received a 510(k) decision of Substantially Equivalent on April 10, 1990, 210 days after the submission was received.

What is the product code of K895524?

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