The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Cpf 550 Lens.
Device ID | K821398 |
510k Number | K821398 |
Device Name: | CORNING CPF 550 LENS |
Classification | Lens, Spectacle, Non-custom (prescription) |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQG |
CFR Regulation Number | 886.5844 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-05-11 |
Decision Date | 1982-06-25 |