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 |