The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Surgicase Guide.
Device ID | K111558 |
510k Number | K111558 |
Device Name: | SURGICASE GUIDE |
Classification | Neurological Stereotaxic Instrument |
Applicant | MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
Contact | Alexandra Razzhivina |
Correspondent | Alexandra Razzhivina MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-03 |
Decision Date | 2012-03-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05420060351105 | K111558 | 000 |
05420060351099 | K111558 | 000 |
05420060351082 | K111558 | 000 |
05420060350115 | K111558 | 000 |
05420060350108 | K111558 | 000 |