The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Boston Contact Lens Case.
Device ID | K951552 |
510k Number | K951552 |
Device Name: | BOSTON CONTACT LENS CASE |
Classification | Case, Contact Lens |
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 | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-04 |
Decision Date | 1995-06-26 |