510(k) K991002

PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP by V. Mueller Neuro/Spine — Product Code FZP

K991002 is an FDA 510(k) premarket notification submitted by V. Mueller Neuro/Spine for the device "PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP". The FDA issued a decision of Substantially Equivalent on June 11, 1999. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. V. Mueller Neuro/Spine has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1999
Date Received
March 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type