The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E2508 Disposable Handswitching Pencil.
| Device ID | K813071 |
| 510k Number | K813071 |
| Device Name: | E2508 DISPOSABLE HANDSWITCHING PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-02 |
| Decision Date | 1981-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524003658 | K813071 | 000 |
| 10884524002224 | K813071 | 000 |
| 30884524000637 | K813071 | 000 |
| 20884524000593 | K813071 | 000 |
| 20884524000524 | K813071 | 000 |
| 20884524000517 | K813071 | 000 |
| 20884524000500 | K813071 | 000 |
| 20884524000494 | K813071 | 000 |
| 30884524000057 | K813071 | 000 |
| 10884524002255 | K813071 | 000 |
| 10884524002972 | K813071 | 000 |
| 10884524003641 | K813071 | 000 |
| 10884524003634 | K813071 | 000 |
| 10884524003627 | K813071 | 000 |
| 10884524003610 | K813071 | 000 |
| 10884524003603 | K813071 | 000 |
| 10884524003016 | K813071 | 000 |
| 10884524002996 | K813071 | 000 |
| 10884524002989 | K813071 | 000 |
| 30884524000040 | K813071 | 000 |