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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, metal
510(k) Number K945027
Device Name TROCHANTER MESH
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 Number878.3300
Classification Product Code
EZX  
Date Received10/13/1994
Decision Date 02/01/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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