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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
Applicant
Origami Surgical LLC
42 Main St. Suite A
Madison,  NJ  07945
Applicant Contact John Gillespie
Correspondent
Clover Medical LLC
79 Haven St.
Dover,  MA  02030
Correspondent Contact John Gillespie
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Codes
GCJ   NAY   NEW  
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
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