510(k) K002276

PSI SKULL CLAMP by V. Mueller Neuro/Spine — Product Code HBL

K002276 is an FDA 510(k) premarket notification submitted by V. Mueller Neuro/Spine for the device "PSI SKULL CLAMP". The FDA issued a decision of Substantially Equivalent on August 29, 2000. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. V. Mueller Neuro/Spine has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2000
Date Received
July 26, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Neurosurgical (Skull Clamp)
Device Class
Class II
Regulation Number
882.4460
Review Panel
NE
Submission Type