The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Coated Electrodes.
| Device ID | K955836 |
| 510k Number | K955836 |
| Device Name: | VALLEYLAB COATED ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Contact | Herbert Vinson |
| Correspondent | Herbert Vinson VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884524002129 | K955836 | 000 |
| 10884521038523 | K955836 | 000 |
| 10884521038479 | K955836 | 000 |
| 10884521037021 | K955836 | 000 |
| 10884521037113 | K955836 | 000 |
| 10884524002217 | K955836 | 000 |
| 10884521175495 | K955836 | 000 |
| 10884521175488 | K955836 | 000 |
| 10884521038172 | K955836 | 000 |
| 10884521037267 | K955836 | 000 |
| 10884521037236 | K955836 | 000 |
| 10884521175419 | K955836 | 000 |
| 20884521175447 | K955836 | 000 |
| 20884521036946 | K955836 | 000 |
| 10884521038530 | K955836 | 000 |
| 10884521038493 | K955836 | 000 |
| 20884521803661 | K955836 | 000 |
| 10884521038394 | K955836 | 000 |
| 10884521713123 | K955836 | 000 |
| 10884521175464 | K955836 | 000 |
| 10884521036949 | K955836 | 000 |
| 10884521175518 | K955836 | 000 |
| 10884521175471 | K955836 | 000 |
| 10884521175426 | K955836 | 000 |
| 10884521038509 | K955836 | 000 |
| 10884521037250 | K955836 | 000 |
| 10884521037137 | K955836 | 000 |
| 10884521037120 | K955836 | 000 |
| 10884524002231 | K955836 | 000 |
| 20884524001477 | K955836 | 000 |
| 30884524000620 | K955836 | 000 |
| 30884524000026 | K955836 | 000 |
| 10884521713147 | K955836 | 000 |
| 10884521713130 | K955836 | 000 |
| 10884521038516 | K955836 | 000 |