The following data is part of a premarket notification filed by Polymer Technology with the FDA for Boston Equalens Ii (oprifocon A) Contact Lens For Orthokeratolgy.
| Device ID | K003933 |
| 510k Number | K003933 |
| Device Name: | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY |
| Classification | Lens, Contact (orthokeratology) |
| Applicant | POLYMER TECHNOLOGY 1400 N GOODMAN ST. Rochester, NY 14603 -0450 |
| Contact | Nancy Abraham |
| Correspondent | Nancy Abraham POLYMER TECHNOLOGY 1400 N GOODMAN ST. Rochester, NY 14603 -0450 |
| Product Code | MUW |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-20 |
| Decision Date | 2001-02-16 |