The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Quadcut.
Device ID | K130608 |
510k Number | K130608 |
Device Name: | QUADCUT |
Classification | Neurological Stereotaxic Instrument |
Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville, CO 80027 |
Contact | Sharon Mcdermott |
Correspondent | Sharon Mcdermott MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville, CO 80027 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-07 |
Decision Date | 2013-08-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUADCUT 85067363 3942261 Live/Registered |
Medtronic Xomed, Inc. 2010-06-21 |