The following data is part of a premarket notification filed by Csi Industries, Inc. with the FDA for Non-prescription Sunglasses.
Device ID | K945922 |
510k Number | K945922 |
Device Name: | NON-PRESCRIPTION SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | CSI INDUSTRIES, INC. 450 WINKS LN. Bensalem, PA 19020 |
Contact | Kathleen Lieberman |
Correspondent | Kathleen Lieberman CSI INDUSTRIES, INC. 450 WINKS LN. Bensalem, PA 19020 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-05 |
Decision Date | 1995-03-03 |