The following data is part of a premarket notification filed by Isolux America with the FDA for Xenon Fiberoptic Light Source, Model 1300 Xsbp.
| Device ID | K022384 |
| 510k Number | K022384 |
| Device Name: | XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ISOLUX AMERICA 1479 RAILHEAD BLVD. Naples, FL 34110 -8444 |
| Contact | Nikolaos Andreoulakis |
| Correspondent | Nikolaos Andreoulakis ISOLUX AMERICA 1479 RAILHEAD BLVD. Naples, FL 34110 -8444 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-22 |
| Decision Date | 2002-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852350007006 | K022384 | 000 |
| 01816835024208 | K022384 | 000 |
| 01816835024192 | K022384 | 000 |
| 01816835024185 | K022384 | 000 |
| 01816835024178 | K022384 | 000 |
| 01816835024161 | K022384 | 000 |
| 01816835024154 | K022384 | 000 |