The following data is part of a premarket notification filed by Jms North America Corp. with the FDA for A.v. Fistula Blunt Needle Set.
| Device ID | K082882 |
| 510k Number | K082882 |
| Device Name: | A.V. FISTULA BLUNT NEEDLE SET |
| Classification | Needle, Fistula |
| Applicant | JMS NORTH AMERICA CORP. 55 NORTHERN BLVD. , SUITE 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Correspondent | Maria F Griffin JMS NORTH AMERICA CORP. 55 NORTHERN BLVD. , SUITE 200 Great Neck, NY 11021 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2009-01-21 |
| Summary: | summary |