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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 K143473
Device Name Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles
Applicant
CAYENNE MEDICAL, INC
16597 N. 92ND ST
SCOTTSDALE,  AZ  85260
Applicant Contact Shima Hashemian
Correspondent
CAYENNE MEDICAL, INC
16597 N. 92ND ST
SCOTTSDALE,  AZ  85260
Correspondent Contact Shima Hashemian
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/05/2014
Decision Date 03/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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