Head Protector

FDA 510(k) K812473 · Maddak, Inc.

Substantially Equivalent

510(k) numberK812473

Submission

Device name
Head Protector
Applicant
Maddak, Inc.
Mchenry, IL, US
Received
August 31, 1981
Decision date
December 2, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FMQ – Restraint, Protective
Device class
Class I (low risk)
Regulation
21 CFR 880.6760
Specialty
General Hospital

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Questions and answers

When was Head Protector cleared by the FDA?

Head Protector (K812473) received a 510(k) decision of Substantially Equivalent on December 2, 1981, 93 days after the submission was received.

What is the product code of K812473?

The FDA product code is FMQ – Restraint, Protective, a Class I (low risk) device regulated under 21 CFR 880.6760.