The following data is part of a premarket notification filed by Eye Care Centers Of America, Inc. with the FDA for Spectacle Frames.
Device ID | K931648 |
510k Number | K931648 |
Device Name: | SPECTACLE FRAMES |
Classification | Frame, Spectacle |
Applicant | EYE CARE CENTERS OF AMERICA, INC. EYE CARE PLAZA 11103 WEST AVE. San Antonio, TX 78213 |
Contact | Michael Minor |
Correspondent | Michael Minor EYE CARE CENTERS OF AMERICA, INC. EYE CARE PLAZA 11103 WEST AVE. San Antonio, TX 78213 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-05 |
Decision Date | 1993-08-05 |