The following data is part of a premarket notification filed by M-pact Corp. with the FDA for M-pact Corneal Light Shield.
| Device ID | K993883 |
| 510k Number | K993883 |
| Device Name: | M-PACT CORNEAL LIGHT SHIELD |
| Classification | Sponge, Ophthalmic |
| Applicant | M-PACT CORP. 1040 0CL PARKWAY, Eudora, KS |
| Contact | Al Boedeker |
| Correspondent | Al Boedeker M-PACT CORP. 1040 0CL PARKWAY, Eudora, KS |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-15 |
| Decision Date | 1999-12-21 |
| Summary: | summary |