The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visi-spear Eye Sponge.
| Device ID | K933872 |
| 510k Number | K933872 |
| Device Name: | VISI-SPEAR EYE SPONGE |
| Classification | Sponge, Ophthalmic |
| Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Contact | David A Clapp |
| Correspondent | David A Clapp VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-06 |
| Decision Date | 1993-12-27 |