The following data is part of a premarket notification filed by Magnivision, Inc. with the FDA for Hard Contact Lens Remover. Item #289.
| Device ID | K872591 |
| 510k Number | K872591 |
| Device Name: | HARD CONTACT LENS REMOVER. ITEM #289 |
| Classification | Inserter/remover Contact Lens |
| Applicant | MAGNIVISION, INC. P.O. BOX 817 Miami, FL 33152 |
| Contact | Steve Felkowitz |
| Correspondent | Steve Felkowitz MAGNIVISION, INC. P.O. BOX 817 Miami, FL 33152 |
| Product Code | KYE |
| CFR Regulation Number | 886.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-01 |
| Decision Date | 1987-08-04 |