The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Stereoplan.
Device ID | K946252 |
510k Number | K946252 |
Device Name: | STEREOPLAN |
Classification | Neurological Stereotaxic Instrument |
Applicant | RADIONICS SOFTWARE APPLICATIONS, INC. P.O. BOX 358 22 TERRY AVENUE Burlington, MA 01803 -0658 |
Contact | Linda Jalbert |
Correspondent | Linda Jalbert RADIONICS SOFTWARE APPLICATIONS, INC. P.O. BOX 358 22 TERRY AVENUE Burlington, MA 01803 -0658 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-23 |
Decision Date | 1995-03-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STEREOPLAN 74459330 1863598 Dead/Cancelled |
SHERWOOD SERVICES AG 1993-11-17 |