FDA 510(k) Applications Submitted by Li Yu
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K203112 |
10/15/2020 |
Disposable Medical Mask |
Yangzhou Runyi Arts & Crafts CO., LTD. |
| K230662 |
03/10/2023 |
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs |
Zhonghong Pulin Medical Products Co.,Ltd. |
| K231029 |
04/11/2023 |
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl |
Zhonghong Pulin Medical Products Co.,Ltd. |
| K162661 |
09/26/2016 |
SavDenTM MTA Root Canal Filling Materials |
tYDS Biotech Incorporation |
| K964321 |
10/29/1996 |
GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
| K190494 |
02/28/2019 |
Infant Incubator |
Ningbo David Medical Device Co.,Ltd |
| K982720 |
08/04/1998 |
H-RAY |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
| K152618 |
09/14/2015 |
PANTHER Cutter Stapler |
B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD |
| K142577 |
09/12/2014 |
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units |
B.J.Z.H.F. Panther Medical Equipment Co. Ltd. |
| K040198 |
01/29/2004 |
LABONE COCAINE METABOLITE MICRO-PLATE EIA |
LABONE, INC. |
| K080381 |
02/13/2008 |
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA |
QUEST DIAGNOSTICS, INC. |
| K062929 |
09/28/2006 |
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA |
QUEST DIAGNOSTICS, INC. |
| K033601 |
11/14/2003 |
LABONE MICRO-PLATE COTININE EIA |
LABONE, INC. |
| K243011 |
09/26/2024 |
Silicone Urethral Catheter (Silicone Urethral Catheter) |
Guangdong Ecan Medical Co., Ltd. |
| K193264 |
11/26/2019 |
Disposable High Speed Air Turbine Handpiece |
Ningbo HPDOVE Dental Instruments Co., Ltd. |
| K212794 |
09/02/2021 |
Accuray Precision Treatment Planning System |
Accuray Incorporated |
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