FDA 510(k) Application Details - K221029

Device Classification Name	More FDA Info for this Device
510(K) Number	K221029
Device Name	PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
Applicant	Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114 US Other 510(k) Applications for this Company
Contact	Megan Sajjad Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2022
Decision Date	10/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review