The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Xenon 300 Light Source.
| Device ID | K980281 |
| 510k Number | K980281 |
| Device Name: | WELCH ALLYN XENON 300 LIGHT SOURCE |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | WELCH ALLYN, INC. 4619 JORDAN RD. Skaneateles Falls, NY 13153 -0187 |
| Contact | Kathy Lowther |
| Correspondent | Kathy Lowther WELCH ALLYN, INC. 4619 JORDAN RD. Skaneateles Falls, NY 13153 -0187 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-26 |
| Decision Date | 1998-02-27 |
| Summary: | summary |