The following data is part of a premarket notification filed by Sun Probe Enterprise Co., Ltd. with the FDA for Sunglasses.
| Device ID | K934020 |
| 510k Number | K934020 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SUN PROBE ENTERPRISE CO., LTD. NO. 15 LANE 306 CHUNG CHENG S. RD YUNG KANG SHAN TAINAN Hsien, Taiwan, R.o.c., TW |
| Contact | Irving Wu |
| Correspondent | Irving Wu SUN PROBE ENTERPRISE CO., LTD. NO. 15 LANE 306 CHUNG CHENG S. RD YUNG KANG SHAN TAINAN Hsien, Taiwan, R.o.c., TW |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-17 |
| Decision Date | 1994-01-06 |