FDA 510(k) Application Details - K223822

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K223822
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Embody, Inc. 4211 Monarch Way, Suite 500 Norfolk, VA 23508 US Other 510(k) Applications for this Company
Contact	Brianna Schehr Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2022
Decision Date	06/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review