The following data is part of a premarket notification filed by A.j. Morgan Ent. with the FDA for A.j. Morgan Sunglasses.
Device ID | K925803 |
510k Number | K925803 |
Device Name: | A.J. MORGAN SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | A.J. MORGAN ENT. P.O. BOX 79215 Los Angeles, CA 90079 -0215 |
Contact | Janet Morgan |
Correspondent | Janet Morgan A.J. MORGAN ENT. P.O. BOX 79215 Los Angeles, CA 90079 -0215 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-16 |
Decision Date | 1993-07-29 |