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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K980103
Device Name ACUMED SUTURE ANCHOR
Applicant
Acu Med, Inc.
10950 SW 5th St.
Suite 170
Beaverton,  OR  97005
Applicant Contact SHARI JEFFERS
Correspondent
Acu Med, Inc.
10950 SW 5th St.
Suite 170
Beaverton,  OR  97005
Correspondent Contact SHARI JEFFERS
Regulation Number888.3040
Classification Product Code
MBI  
Date Received01/12/1998
Decision Date 03/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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