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Found 1 results

510(k) Data Aggregation

K Number

Device Name

FULL BODY RESTRAINT SYSTEM

Manufacturer

GILLEN INDUSTRIES

Date Cleared

1997-08-15

(74 days)

Product Code

FMQ, FMO

Regulation Number

880.6760

Why did this record match?

Applicant Name (Manufacturer) :

GILLEN INDUSTRIES

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

New to protect patient from injury or injury to others.

Device Description

Full Body Restraint System

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