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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K060014
Device Name INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS
Applicant
Intelifuse, Inc.
5582 Chalon Rd.
Yorba Linda,  CA  92886
Applicant Contact SHARON ROCKWELL
Correspondent
Intelifuse, Inc.
5582 Chalon Rd.
Yorba Linda,  CA  92886
Correspondent Contact SHARON ROCKWELL
Regulation Number888.3030
Classification Product Code
JDR  
Date Received01/03/2006
Decision Date 04/03/2006
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
Recalls CDRH Recalls
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