The following data is part of a premarket notification filed by Nextec Corp. with the FDA for Nextec Fiberoptic Illuminator 300 Watt Xenon.
| Device ID | K921646 |
| 510k Number | K921646 |
| Device Name: | NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | NEXTEC CORP. 2629 S. HORSESHOE DR. Naples, FL 33942 |
| Contact | Jack Kloots |
| Correspondent | Jack Kloots NEXTEC CORP. 2629 S. HORSESHOE DR. Naples, FL 33942 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-05-13 |