The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Boston Cleaner Ii.
| Device ID | K923437 |
| 510k Number | K923437 |
| Device Name: | BOSTON CLEANER II |
| Classification | Accessories, Soft Lens Products |
| Applicant | POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
| Contact | Debra L.b. Ketchum |
| Correspondent | Debra L.b. Ketchum POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-13 |
| Decision Date | 1992-10-28 |