The following data is part of a premarket notification filed by Rockway Enterprises, Inc. with the FDA for Visoprotect: Occular Shield.
| Device ID | K850099 |
| 510k Number | K850099 |
| Device Name: | VISOPROTECT: OCCULAR SHIELD |
| Classification | Pad, Eye |
| Applicant | ROCKWAY ENTERPRISES, INC. P.O. BOX 8 ST GEORGE, ME 04857 |
| Contact | ONAT |
| Correspondent | ONAT ROCKWAY ENTERPRISES, INC. P.O. BOX 8 ST GEORGE, ME 04857 |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-11 |
| Decision Date | 1985-03-20 |