The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for Re-usable Monopolar Needle.
| Device ID | K953886 |
| 510k Number | K953886 |
| Device Name: | RE-USABLE MONOPOLAR NEEDLE |
| 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 | 1995-08-17 |
| Decision Date | 1995-10-31 |