The following data is part of a premarket notification filed by White Knight Healthcare with the FDA for Clear Lens Endoscopic Fog Reduction Device.
| Device ID | K942576 |
| 510k Number | K942576 |
| Device Name: | CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | WHITE KNIGHT HEALTHCARE P.O. BOX 6874 175 DEAVERVIEW ROAD Asheville, NC 28816 |
| Contact | Frank Dastoli |
| Correspondent | Frank Dastoli WHITE KNIGHT HEALTHCARE P.O. BOX 6874 175 DEAVERVIEW ROAD Asheville, NC 28816 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1994-07-05 |