FDA 510(k) Application Details - DEN220082

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220082
Device Name	Bateman Bottle
Applicant	Empower Medical Devices 8964 Little Mountain Rd Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Jared Finney 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