The following data is part of a premarket notification filed by Jms North America Corporation with the FDA for Wingeater V2.
| Device ID | K111948 |
| 510k Number | K111948 |
| Device Name: | WINGEATER V2 |
| Classification | Needle, Fistula |
| Applicant | JMS NORTH AMERICA CORPORATION 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith JMS NORTH AMERICA CORPORATION 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-08 |
| Decision Date | 2011-10-24 |
| Summary: | summary |