The following data is part of a premarket notification filed by Jms North America Corporation with the FDA for Jms Harmony A.v. Fistula Needle Set.
| Device ID | K151017 |
| 510k Number | K151017 |
| Device Name: | JMS Harmony A.V. Fistula Needle Set |
| Classification | Needle, Fistula |
| Applicant | JMS NORTH AMERICA CORPORATION 22320 FOOTHILL BLVD SUITE 350 Hayward, CA 94541 |
| Contact | Sho Hosoki |
| Correspondent | Sho Hosoki JMS NORTH AMERICA CORPORATION 22320 FOOTHILL BLVD SUITE 350 Hayward, CA 94541 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-16 |
| Decision Date | 2015-05-13 |
| Summary: | summary |