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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 K152236
Device Name KATOR Suture Anchor
Applicant
KATOR LLC
124 South 600 West, Suite 100
Logan,  UT  84321
Applicant Contact Robert Hoy
Correspondent
KATOR LLC
124 South 600 West, Suite 100
Logan,  UT  84321
Correspondent Contact Robert Hoy
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/10/2015
Decision Date 11/04/2015
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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