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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 K202950
Device Name StitchKit COMBO
Applicant
Origami Surgical
79 Haven St.
Dover,  MA  02030
Applicant Contact John Gillespie
Correspondent
Origami Surgical
79 Haven St.
Dover,  MA  02030
Correspondent Contact John Gillespie
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Codes
GAP   GCJ   NAY  
Date Received09/30/2020
Decision Date 02/23/2021
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
Predetermined Change
Control Plan Authorized		 No
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