The following data is part of a premarket notification filed by Highpoint Medical Corp. with the FDA for Fog Control, Lens Fog Reduction Device.
| Device ID | K932300 |
| 510k Number | K932300 |
| Device Name: | FOG CONTROL, LENS FOG REDUCTION DEVICE |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | HIGHPOINT MEDICAL CORP. P.O. BOX 170873 Arlington, TX 76003 |
| Contact | Roger Liebelt |
| Correspondent | Roger Liebelt HIGHPOINT MEDICAL CORP. P.O. BOX 170873 Arlington, TX 76003 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-12 |
| Decision Date | 1993-09-17 |