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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
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