The following data is part of a premarket notification filed by Jms North America Corp. with the FDA for Jms Blood Tubing Sets.
| Device ID | K032975 |
| 510k Number | K032975 |
| Device Name: | JMS BLOOD TUBING SETS |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Contact | Swee Cheau |
| Correspondent | Swee Cheau JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-24 |
| Decision Date | 2004-08-16 |
| Summary: | summary |