The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Fiber Optic Light Source Cat. #e9100.
| Device ID | K882742 |
| 510k Number | K882742 |
| Device Name: | FIBER OPTIC LIGHT SOURCE CAT. #E9100 |
| 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 | 1988-07-01 |
| Decision Date | 1988-07-18 |