The following data is part of a premarket notification filed by Kylie Enterprise Co. Ltd. with the FDA for Sunglasses.
| Device ID | K961034 |
| 510k Number | K961034 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | KYLIE ENTERPRISE CO. LTD. MIN-LO ST., NO.3, 3RD. FL., ALLEY 8 LANE 31 Yung-ho, Taipei Hsien, TW |
| Contact | Peter Liaw |
| Correspondent | Peter Liaw KYLIE ENTERPRISE CO. LTD. MIN-LO ST., NO.3, 3RD. FL., ALLEY 8 LANE 31 Yung-ho, Taipei Hsien, TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-04-24 |