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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 K211792
Device Name StitchKit
Applicant
Origami Surgical Inc .
42 Main St.
Madison,  NJ  07940
Applicant Contact John Gillespie
Correspondent
Origami Surgical Inc .
42 Main St.
Madison,  NJ  07940
Correspondent Contact John Gillespie
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Codes
GAT   GCJ   NAY  
Date Received06/10/2021
Decision Date 07/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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