The following data is part of a premarket notification filed by M.s.g. Health Systems, Inc. with the FDA for Visoprotect Occular Shield.
| Device ID | K850005 |
| 510k Number | K850005 |
| Device Name: | VISOPROTECT OCCULAR SHIELD |
| Classification | Pad, Eye |
| Applicant | M.S.G. HEALTH SYSTEMS, INC. BOX 3324 WOODSIDE RD. Brunswick, ME 04011 |
| Contact | Maurice Ghaly |
| Correspondent | Maurice Ghaly M.S.G. HEALTH SYSTEMS, INC. BOX 3324 WOODSIDE RD. Brunswick, ME 04011 |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-02 |
| Decision Date | 1985-03-20 |