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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, orthopedic, dc-powered motor and accessory/attachment
510(k) Number K960711
Device Name ACUMED BONE GRAFT SYSTEM
Applicant
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Applicant Contact SHARI L JEFFERS
Correspondent
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Correspondent Contact SHARI L JEFFERS
Regulation Number878.4820
Classification Product Code
KIJ  
Date Received02/21/1996
Decision Date 05/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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