The following data is part of a premarket notification filed by Ialin Optical Mfg., (h.k.) Co. Ltd. with the FDA for Sunglasses.
| Device ID | K946381 |
| 510k Number | K946381 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | IALIN OPTICAL MFG., (H.K.) CO. LTD. 2/F., MIDDLE BLK, MAN WAI BLDG 9 MAN CHEONG ST. FERRY POINT Yaumati, Kln., HK |
| Contact | Wong Chi Kau |
| Correspondent | Wong Chi Kau IALIN OPTICAL MFG., (H.K.) CO. LTD. 2/F., MIDDLE BLK, MAN WAI BLDG 9 MAN CHEONG ST. FERRY POINT Yaumati, Kln., HK |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-27 |
| Decision Date | 1995-02-22 |