The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Boston Vii.
Device ID | K942365 |
510k Number | K942365 |
Device Name: | BOSTON VII |
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 | 1994-05-17 |
Decision Date | 1994-06-23 |