The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Vector Vision Hip.
Device ID | K072716 |
510k Number | K072716 |
Device Name: | VECTOR VISION HIP |
Classification | Neurological Stereotaxic Instrument |
Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
Contact | Benjamin Wagner |
Correspondent | Benjamin Wagner BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-12 |
Decision Date | 2007-10-12 |
Summary: | summary |