The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Boston Advance Cleaner.
| Device ID | K974466 |
| 510k Number | K974466 |
| Device Name: | BOSTON ADVANCE CLEANER |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
| Contact | Dogulas J Fortunato |
| Correspondent | Dogulas J Fortunato POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-26 |
| Decision Date | 1998-02-19 |
| Summary: | summary |