The following data is part of a premarket notification filed by Products For Medicine with the FDA for I-spose Eye Shield.
| Device ID | K883658 |
| 510k Number | K883658 |
| Device Name: | I-SPOSE EYE SHIELD |
| Classification | Mask, Surgical |
| Applicant | PRODUCTS FOR MEDICINE 17853 SANTIAGO #107-347 Villa Park, CA 92667 |
| Contact | Fred Fechtman |
| Correspondent | Fred Fechtman PRODUCTS FOR MEDICINE 17853 SANTIAGO #107-347 Villa Park, CA 92667 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-26 |
| Decision Date | 1988-10-25 |