The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model E278or-asp Series Retractable.
| Device ID | K944244 |
| 510k Number | K944244 |
| Device Name: | MODEL E278OR-ASP SERIES RETRACTABLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Contact | Julie Ross |
| Correspondent | Julie Ross 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 | 1994-09-01 |
| Decision Date | 1994-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524000739 | K944244 | 000 |
| 20884524000722 | K944244 | 000 |
| 20884524000715 | K944244 | 000 |
| 20884524000708 | K944244 | 000 |
| 20884524000418 | K944244 | 000 |