The following data is part of a premarket notification filed by Jms North America Corp. with the FDA for Jms Blunt A. V. Fistula Needle Set With Site Preparation Tool Model 820-5300, 820-6300 And 820-7300.
| Device ID | K093637 |
| 510k Number | K093637 |
| Device Name: | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 |
| Classification | Needle, Fistula |
| Applicant | JMS NORTH AMERICA CORP. 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith JMS NORTH AMERICA CORP. 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-24 |
| Decision Date | 2010-02-09 |
| Summary: | summary |