The following data is part of a premarket notification filed by Jms North America Corp. with the FDA for Jms Sysloc Mini Avf And Apheresis Needle Sets.
| Device ID | K070234 |
| 510k Number | K070234 |
| Device Name: | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Contact | Swee Cheau Chong |
| Correspondent | Swee Cheau Chong JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-05-22 |
| Summary: | summary |