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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, operating-room, electrical
510(k) Number K964273
Device Name DURA-BOARD ARMBOARD
Applicant
ALLEN MEDICAL SYSTEMS, INC.
15627 NEO PKWY.
CLEVELAND,  OH  44128
Applicant Contact SUZANNE K RATZLOFF
Correspondent
ALLEN MEDICAL SYSTEMS, INC.
15627 NEO PKWY.
CLEVELAND,  OH  44128
Correspondent Contact SUZANNE K RATZLOFF
Regulation Number878.4960
Classification Product Code
GDC  
Subsequent Product Codes
FQO   FWW  
Date Received10/28/1996
Decision Date 01/08/1997
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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