The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Boston Es Multivision (enflufocon A) Contact Lens.
| Device ID | K970698 |
| 510k Number | K970698 |
| Device Name: | BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
| Contact | Douglas J Fortunato |
| Correspondent | Douglas J Fortunato POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-25 |
| Decision Date | 1997-05-06 |
| Summary: | summary |