Cleared Traditional

HEAD PROTECTOR

K812473 · Maddak, Inc. · General Hospital
Dec 1981
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K812473 is an FDA 510(k) clearance for the HEAD PROTECTOR, a Restraint, Protective (Class I — General Controls, product code FMQ), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1981, 93 days after receiving the submission on August 31, 1981. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6760.

Submission Details

510(k) Number K812473 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1981
Decision Date December 02, 1981
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FMQ — Restraint, Protective
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6760

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