The following data is part of a premarket notification filed by Jay-y Enterprises Co., Inc. with the FDA for None-generic.
Device ID | K940726 |
510k Number | K940726 |
Device Name: | NONE-GENERIC |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | JAY-Y ENTERPRISES CO., INC. 632 NEW YORK DR. Pomona, CA 91768 |
Contact | James Chen |
Correspondent | James Chen JAY-Y ENTERPRISES CO., INC. 632 NEW YORK DR. Pomona, CA 91768 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-18 |
Decision Date | 1994-04-11 |