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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
Predetermined Change
Control Plan Authorized		 No
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