The following data is part of a premarket notification filed by Woodbine Ptical Corp. with the FDA for Woodbine Xt350, Xenon Arc Light Source.
| Device ID | K922820 |
| 510k Number | K922820 |
| Device Name: | WOODBINE XT350, XENON ARC LIGHT SOURCE |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | WOODBINE PTICAL CORP. 685 SOUTH ST. Wrentham, MA 02093 |
| Contact | Robert H Segersten |
| Correspondent | Robert H Segersten WOODBINE PTICAL CORP. 685 SOUTH ST. Wrentham, MA 02093 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-11 |
| Decision Date | 1992-09-02 |