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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 K151068
Device Name SureLock W Suture Anchor
Applicant
CAYENNE MEDICAL, INC
16597 N 92ND STREET
SCOTTSDALE,  AZ  85260
Applicant Contact SHIMA HASHEMIAN
Correspondent
CAYENNE MEDICAL, INC
16597 N 92ND STREET., SUITE 101
SCOTTSDALE,  AZ  85260
Correspondent Contact SHIMA HASHEMIAN
Regulation Number888.3040
Classification Product Code
MBI  
Date Received04/21/2015
Decision Date 07/24/2015
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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