FDA 510(k) Application Details - K193438

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K193438
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	Pro Med Instruments GmbH Boetzinger Str. 38 Freiburg 79111 DE Other 510(k) Applications for this Company
Contact	Muhammad Zubair Other 510(k) Applications for this Contact
Regulation Number	882.4460   More FDA Info for this Regulation Number
Classification Product Code	HBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2019
Decision Date	06/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review