FDA 510(k) Application Details - K191287

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K191287
Device Name	Staple, Implantable
Applicant	Davol Inc., Subsidiary of C.R. Bard 100 Crossings Blvd Warwick, RI 02886 US Other 510(k) Applications for this Company
Contact	Angelica Hutchison Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2019
Decision Date	07/16/2019
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