The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for 22mm Stainless Steel Disc Electrode, With Pin.
| Device ID | K953219 |
| 510k Number | K953219 |
| Device Name: | 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN |
| 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 |