The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E2550 Reusable Handswitching Pencil.
| Device ID | K942183 |
| 510k Number | K942183 |
| Device Name: | E2550 REUSABLE HANDSWITCHING PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Peggy Walline |
| Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. 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 | 1994-05-04 |
| Decision Date | 1994-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524001913 | K942183 | 000 |
| 10884524001593 | K942183 | 000 |