The following data is part of a premarket notification filed by Products For Medicine with the FDA for White Sun Light Source Model #: Xl300 And #: Xl175.
| Device ID | K963227 |
| 510k Number | K963227 |
| Device Name: | WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | PRODUCTS FOR MEDICINE 52337 AVENIDA NAVARRO La Quinta, CA 92253 |
| Contact | D'arcy Deeks |
| Correspondent | D'arcy Deeks PRODUCTS FOR MEDICINE 52337 AVENIDA NAVARRO La Quinta, CA 92253 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-19 |
| Decision Date | 1996-10-23 |