The following data is part of a premarket notification filed by Jms North America Corporation with the FDA for Jms Safe Wing Cath (swc).
| Device ID | K121488 |
| 510k Number | K121488 |
| Device Name: | JMS SAFE WING CATH (SWC) |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | JMS NORTH AMERICA CORPORATION 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Yolanda Smith JMS NORTH AMERICA CORPORATION 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-18 |
| Decision Date | 2013-03-05 |
| Summary: | summary |