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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Absorbable, Staple Line Reinforcement
510(k) Number K221487
Device Name NEOVEIL Staple Line Reinforcement
Applicant
Gunze Limited
46 Natsumegaichi, Aono
Ayabe, Kyoto,  JP 623-8513
Applicant Contact Hidenori Nishioka
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number878.3300
Classification Product Code
OXC  
Date Received05/23/2022
Decision Date 08/26/2022
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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