510(k) K991002
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