The following data is part of a premarket notification filed by V. Mueller Neuro/spine with the FDA for Psi Titanium Aneurysm Clip.
Device ID | K991959 |
510k Number | K991959 |
Device Name: | PSI TITANIUM ANEURYSM CLIP |
Classification | Clip, Aneurysm |
Applicant | V. MUELLER NEURO/SPINE 360 INDUSTRIAL RD., UNIT H San Carlos, CA 94070 |
Contact | Terry Johnston |
Correspondent | Terry Johnston V. MUELLER NEURO/SPINE 360 INDUSTRIAL RD., UNIT H San Carlos, CA 94070 |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-10 |
Decision Date | 2000-01-06 |
Summary: | summary |