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 |