The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for 32mm Nickel Plated Disc Electrode.
| Device ID | K953220 |
| 510k Number | K953220 |
| Device Name: | 32MM NICKEL PLATED DISC 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 | 1995-07-10 |
| Decision Date | 1995-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816020020696 | K953220 | 000 |
| 00816020020689 | K953220 | 000 |
| 00816020020672 | K953220 | 000 |
| 00816020020665 | K953220 | 000 |