The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E0520-trigger Switch And Cord/e0521-trigger Switch.
| Device ID | K970140 |
| 510k Number | K970140 |
| Device Name: | E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | John Dicaro |
| Correspondent | John Dicaro 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 | 1997-01-15 |
| Decision Date | 1997-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524000425 | K970140 | 000 |