The following data is part of a premarket notification filed by Xuzhou Kernel Medical Equipment Co., Ltd. with the FDA for Uv Phototherapy.
| Device ID | K132643 |
| 510k Number | K132643 |
| Device Name: | UV PHOTOTHERAPY |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2014-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06928798600063 | K132643 | 000 |
| 06928798600056 | K132643 | 000 |
| 06928798600049 | K132643 | 000 |
| 06928798600032 | K132643 | 000 |
| 06928798600025 | K132643 | 000 |
| 06928798600018 | K132643 | 000 |