FDA 510(k) Application Details - K230256

Device Classification Name	Rongeur, Manual   More FDA Info for this Device
510(K) Number	K230256
Device Name	Rongeur, Manual
Applicant	Morpheus AG Bahnhofstra▀e 18 Spaichingen 78549 DE Other 510(k) Applications for this Company
Contact	Dimitri Krutsch Other 510(k) Applications for this Contact
Regulation Number	882.4840   More FDA Info for this Regulation Number
Classification Product Code	HAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2023
Decision Date	03/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review