The following data is part of a premarket notification filed by Isolux America with the FDA for Endoscopic Fiberoptic Cable.
| Device ID | K991208 |
| 510k Number | K991208 |
| Device Name: | ENDOSCOPIC FIBEROPTIC CABLE |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | ISOLUX AMERICA 1479 RAILHEAD BLVD. Naples, FL 34110 -8444 |
| Contact | Stuart L Mcghee |
| Correspondent | Stuart L Mcghee ISOLUX AMERICA 1479 RAILHEAD BLVD. Naples, FL 34110 -8444 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-09 |
| Decision Date | 1999-06-23 |