The following data is part of a premarket notification filed by Aptaker Co., Inc. with the FDA for Spectacle Frames.
Device ID | K924232 |
510k Number | K924232 |
Device Name: | SPECTACLE FRAMES |
Classification | Frame, Spectacle |
Applicant | APTAKER CO., INC. 17802 DAVENPORT #102 Dallas, TX 75252 |
Contact | Rodney Hayes |
Correspondent | Rodney Hayes APTAKER CO., INC. 17802 DAVENPORT #102 Dallas, TX 75252 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-24 |
Decision Date | 1992-11-05 |