Dermaland Dural Hooks

FDA 510(k) K832343 · National Fabtronix, Inc.

Substantially Equivalent

510(k) numberK832343

Submission

Device name
Dermaland Dural Hooks
Applicant
National Fabtronix, Inc.
Mchenry, IL, US
Received
July 18, 1983
Decision date
August 12, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HAO – Instrument, Surgical, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 882.4535
Specialty
Neurology

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Questions and answers

When was Dermaland Dural Hooks cleared by the FDA?

Dermaland Dural Hooks (K832343) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 25 days after the submission was received.

What is the product code of K832343?

The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.