The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Expandacell Eye Spear, Eye Wick, Wick Drain And Corneal Shield.
| Device ID | K964855 |
| 510k Number | K964855 |
| Device Name: | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD |
| Classification | Sponge, Ophthalmic |
| Applicant | SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Contact | Sarah Maxwell Lake |
| Correspondent | Sarah Maxwell Lake SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-04 |
| Decision Date | 1997-03-04 |