FDA 510(k) Application Details - DEN220082

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220082
Device Name	Breast Implant Removal Device (BIRD)
Applicant	Gaylord Solutions, LLC 1258 Old 27 N Gaylord, MI 49735 US Other 510(k) Applications for this Company
Contact	Alex Cerveniak Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2022
Decision Date	04/20/2023
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review