The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for Re-usable Bipolar Concentric Needle(237-xxx-24,237-xxx-24stp, 237-xxx-24tp,237-xxx-24stp.
| Device ID | K960591 |
| 510k Number | K960591 |
| Device Name: | RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| 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 | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-12 |
| Decision Date | 1996-06-13 |