The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visi-wipe.
| Device ID | K884924 | 
| 510k Number | K884924 | 
| Device Name: | VISI-WIPE | 
| Classification | Burr, Corneal, Manual | 
| Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 | 
| Contact | Liaquat Allarakhia | 
| Correspondent | Liaquat Allarakhia VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 | 
| Product Code | HOF | 
| CFR Regulation Number | 886.4350 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1988-11-28 | 
| Decision Date | 1989-01-31 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VISI-WIPE  73800341  1574676 Dead/Cancelled | VISITEC COMPANY 1989-05-15 |