FDA 510(k) Application Details - K221487

Device Classification Name	More FDA Info for this Device
510(K) Number	K221487
Device Name	NEOVEIL Staple Line Reinforcement
Applicant	Gunze Limited 46 Natsumegaichi, Aono Ayabe, Kyoto 623-8513 JP Other 510(k) Applications for this Company
Contact	Hidenori Nishioka Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2022
Decision Date	08/26/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review