The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for Emg Disc Recording Electrode.
| Device ID | K953361 |
| 510k Number | K953361 |
| Device Name: | EMG DISC RECORDING ELECTRODE |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1996-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816020020603 | K953361 | 000 |
| 00816020020597 | K953361 | 000 |
| 00816020020580 | K953361 | 000 |
| 00816020020573 | K953361 | 000 |
| 00816020020566 | K953361 | 000 |
| 00816020020559 | K953361 | 000 |