The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for Disp. Concentric Needle Electrode (dcp-30, Dcp-45).
| Device ID | K896370 |
| 510k Number | K896370 |
| Device Name: | DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) |
| Classification | Electrode, Needle |
| Applicant | CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020 |
| Contact | Richard Kaiser |
| Correspondent | Richard Kaiser CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1989-12-22 |