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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, Biodegradable, Soft Tissue
510(k) Number K162429
Device Name ZipE Knotless Tissue Repair and Attachment Devices
Applicant
Ziptek, LLC
1250 S Tamiami Trl. Suite 303
Sarasota,  FL  34239
Applicant Contact William F. Bennett
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
KGS   MBI  
Date Received08/30/2016
Decision Date 03/13/2017
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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