The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Jms Needles And Jms Syringes.
Device ID | K871965 |
510k Number | K871965 |
Device Name: | JMS NEEDLES AND JMS SYRINGES |
Classification | Syringe, Piston |
Applicant | JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
Contact | Sakae Ogata |
Correspondent | Sakae Ogata JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-19 |
Decision Date | 1987-09-04 |