The following data is part of a premarket notification filed by Eyetel Optics, Inc. with the FDA for Frame - Spectacle.
Device ID | K931972 |
510k Number | K931972 |
Device Name: | FRAME - SPECTACLE |
Classification | Frame, Spectacle |
Applicant | EYETEL OPTICS, INC. 14301 S.W. 119 AVE. Miami, FL 33186 |
Contact | Frances Klisiewecz |
Correspondent | Frances Klisiewecz EYETEL OPTICS, INC. 14301 S.W. 119 AVE. Miami, FL 33186 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-22 |
Decision Date | 1993-10-01 |