The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Boston(r) 7 - 30(enflufocon A).
| Device ID | K943177 |
| 510k Number | K943177 |
| Device Name: | BOSTON(R) 7 - 30(ENFLUFOCON A) |
| Classification | Lens, Contact (other Material) - Daily |
| 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 | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-01 |
| Decision Date | 1994-08-25 |