The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Various Syringes W/needles, W/out Needles, Needles.
| Device ID | K864747 | 
| 510k Number | K864747 | 
| Device Name: | VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES | 
| 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 | 1986-12-05 | 
| Decision Date | 1986-12-29 |