The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co, Ltd with the FDA for Suntouch Eye Spear.
| Device ID | K132796 |
| 510k Number | K132796 |
| Device Name: | SUNTOUCH EYE SPEAR |
| Classification | Sponge, Ophthalmic |
| Applicant | HUIZHOU FORYOU MEDICAL DEVICES CO, LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong HUIZHOU FORYOU MEDICAL DEVICES CO, LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-06 |
| Decision Date | 2013-10-30 |
| Summary: | summary |