The following data is part of a premarket notification filed by Dsp Worldwide with the FDA for Xenon Lightsource.
Device ID | K962365 |
510k Number | K962365 |
Device Name: | XENON LIGHTSOURCE |
Classification | Light Source, Endoscope, Xenon Arc |
Applicant | DSP WORLDWIDE 49 PLAIN ST. North Attleboro, MA 02760 |
Contact | Rosina Robinson |
Correspondent | Rosina Robinson DSP WORLDWIDE 49 PLAIN ST. North Attleboro, MA 02760 |
Product Code | GCT |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-19 |
Decision Date | 1996-07-18 |
Summary: | summary |