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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 K183501
Device Name Parcus Twist AP Suture Anchors
Applicant
Parcus Medical, LLC
6423 Parkland Dr.
Sarasota,  FL  34231
Applicant Contact Paul Vagts
Correspondent
Parcus Medical, LLC
6423 Parkland Dr.
Sarasota,  FL  34231
Correspondent Contact Paul Vagts
Regulation Number888.3030
Classification Product Code
MAI  
Date Received12/17/2018
Decision Date 03/15/2019
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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