The following data is part of a premarket notification filed by The Electrode Store, Inc. with the FDA for Protectrode System.
| Device ID | K926094 |
| 510k Number | K926094 |
| Device Name: | PROTECTRODE SYSTEM |
| Classification | Electrode, Needle |
| Applicant | THE ELECTRODE STORE, INC. 240 AUBURN WAY S., P.O. BOX 188 Enumclaw, WA 98022 |
| Contact | Timothy S Cooke |
| Correspondent | Timothy S Cooke THE ELECTRODE STORE, INC. 240 AUBURN WAY S., P.O. BOX 188 Enumclaw, WA 98022 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-02 |
| Decision Date | 1995-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816022023619 | K926094 | 000 |
| 00816022020182 | K926094 | 000 |
| 00816022020175 | K926094 | 000 |
| 00816022020168 | K926094 | 000 |
| 00816022020151 | K926094 | 000 |
| 00816022020144 | K926094 | 000 |
| 00816022020137 | K926094 | 000 |
| 00816022020120 | K926094 | 000 |
| 00816022020113 | K926094 | 000 |
| 00816022020106 | K926094 | 000 |
| 00816022020090 | K926094 | 000 |
| 00816022020083 | K926094 | 000 |
| 00816022020076 | K926094 | 000 |
| 00816022020069 | K926094 | 000 |
| 00816022020052 | K926094 | 000 |
| 00816022020045 | K926094 | 000 |
| 00816022020038 | K926094 | 000 |
| 00816022020021 | K926094 | 000 |
| 00816022020199 | K926094 | 000 |
| 00816022020205 | K926094 | 000 |
| 00816022023589 | K926094 | 000 |
| 00816022023138 | K926094 | 000 |
| 00816022022322 | K926094 | 000 |
| 00816022022278 | K926094 | 000 |
| 00816022022254 | K926094 | 000 |
| 00816022022247 | K926094 | 000 |
| 00816022022230 | K926094 | 000 |
| 00816022022179 | K926094 | 000 |
| 00816022022056 | K926094 | 000 |
| 00816022022049 | K926094 | 000 |
| 00816022020694 | K926094 | 000 |
| 00816022020687 | K926094 | 000 |
| 00816022020519 | K926094 | 000 |
| 00816022020502 | K926094 | 000 |
| 00816022020496 | K926094 | 000 |
| 00816022020489 | K926094 | 000 |
| 00816022020472 | K926094 | 000 |
| 00816022020007 | K926094 | 000 |