The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Cosgrove Depth Electrode Kit(cdek).
| Device ID | K961858 |
| 510k Number | K961858 |
| Device Name: | COSGROVE DEPTH ELECTRODE KIT(CDEK) |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Amy J Laforte Ph.d. |
| Correspondent | Amy J Laforte Ph.d. RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-14 |
| Decision Date | 1996-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M433CDEKGS1 | K961858 | 000 |