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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K873370
Device Name ALLEN MALLEABLE ANESTHESIA SCREEN
Applicant
EDGEWATER MEDICAL EQUIPMENT SYSTEMS
6263 MAYFIELD RD.
SUITE 206
MAYFIELD HTS.,  OH  44124
Applicant Contact DANIEL ALLEN
Correspondent
EDGEWATER MEDICAL EQUIPMENT SYSTEMS
6263 MAYFIELD RD.
SUITE 206
MAYFIELD HTS.,  OH  44124
Correspondent Contact DANIEL ALLEN
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received08/21/1987
Decision Date 09/11/1987
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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