FDA 510(k) Application Details - K232372

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K232372
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	Peters Surgical 10 Cordage Park Cir #100 Plymouth, MA 02360 US Other 510(k) Applications for this Company
Contact	Ellen Henke-Knupp Other 510(k) Applications for this Contact
Regulation Number	878.4493   More FDA Info for this Regulation Number
Classification Product Code	GAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2023
Decision Date	07/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review