ALLEN PRONE ARMBOARD

Board, Arm (with Cover), Sterile

EDGEWATER MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Edgewater Medical Systems, Inc. with the FDA for Allen Prone Armboard.

Pre-market Notification Details

Device IDK884838
510k NumberK884838
Device Name:ALLEN PRONE ARMBOARD
ClassificationBoard, Arm (with Cover), Sterile
Applicant EDGEWATER MEDICAL SYSTEMS, INC. 6263 MAYFIELD RD #206 Mayfield Hts.,  OH  44124
ContactDaniel Allen
CorrespondentDaniel Allen
EDGEWATER MEDICAL SYSTEMS, INC. 6263 MAYFIELD RD #206 Mayfield Hts.,  OH  44124
Product CodeBTX  
CFR Regulation Number878.3910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-21
Decision Date1988-12-15

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