The following data is part of a premarket notification filed by Jiangyin Caina Technology Co., Ltd with the FDA for Syringes And Needles.
Device ID | K113091 |
510k Number | K113091 |
Device Name: | SYRINGES AND NEEDLES |
Classification | Syringe, Piston |
Applicant | JIANGYIN CAINA TECHNOLOGY CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
Contact | Diana Hong |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-10-19 |
Decision Date | 2011-10-28 |
Summary: | summary |