The following data is part of a premarket notification filed by Polymer Technology Div. Wilmington Partners, L.p. with the FDA for Boston Contact Lens Case.
Device ID | K962512 |
510k Number | K962512 |
Device Name: | BOSTON CONTACT LENS CASE |
Classification | Case, Contact Lens |
Applicant | POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. 1400 N. GOODMAN ST. Rochester, NY 14692 |
Contact | Debra L.b. Ketchum |
Correspondent | Debra L.b. Ketchum POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. 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 | 1996-06-27 |
Decision Date | 1996-07-12 |
Summary: | summary |