ALLEN LATERAL ARMBOARD

K881292 · Edgewater Medical Systems, Inc. · BTX · Apr 7, 1988 · General, Plastic Surgery

Device Facts

Record IDK881292
Device NameALLEN LATERAL ARMBOARD
ApplicantEdgewater Medical Systems, Inc.
Product CodeBTX · General, Plastic Surgery
Decision DateApr 7, 1988
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.3910
Device ClassClass 1

Regulatory Classification

Identification

A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

Innolitics

Panel 1

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