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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 K191783
Device Name Parcus Synd-EZ Ti
Applicant
Parcus Medical, LLC
6423 Parkland Dr
Sarasota,  FL  34243
Applicant Contact Paul Vagts
Correspondent
Parcus Medical, LLC
6423 Parkland Dr
Sarasota,  FL  34243
Correspondent Contact Paul Vagts
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HTN  
Date Received07/03/2019
Decision Date 10/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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