The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Eye Shield.
| Device ID | K843197 |
| 510k Number | K843197 |
| Device Name: | VISITEC EYE SHIELD |
| Classification | Pad, Eye |
| Applicant | VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
| Contact | Eugene H. Beckstein |
| Correspondent | Eugene H. Beckstein VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-14 |
| Decision Date | 1984-10-05 |