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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name board, arm (with cover), sterile
510(k) Number K884838
Device Name ALLEN PRONE ARMBOARD
Applicant
EDGEWATER MEDICAL SYSTEMS, INC.
6263 MAYFIELD RD #206
MAYFIELD HTS.,  OH  44124
Applicant Contact DANIEL ALLEN
Correspondent
EDGEWATER MEDICAL SYSTEMS, INC.
6263 MAYFIELD RD #206
MAYFIELD HTS.,  OH  44124
Correspondent Contact DANIEL ALLEN
Regulation Number878.3910
Classification Product Code
BTX  
Date Received11/21/1988
Decision Date 12/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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