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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, absorbable, synthetic, polyglycolic acid
510(k) Number K173874
Device Name StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
Origami Surgical LLC
42 Main St. Suite A
Madison,  NJ  07945
Applicant Contact John Gillespie
Clover Medical LLC
79 Haven St.
Dover,  MA  02030
Correspondent Contact John Gillespie
Regulation Number878.4493
Classification Product Code
Subsequent Product Codes
Date Received12/21/2017
Decision Date 05/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No