The following data is part of a premarket notification filed by Act Medical, Inc. with the FDA for Flexneedle Plus.
| Device ID | K990693 |
| 510k Number | K990693 |
| Device Name: | FLEXNEEDLE PLUS |
| Classification | Set, Administration, Intravascular |
| Applicant | ACT MEDICAL, INC. 150 CALIFORNIA ST. Newton, MA 02458 |
| Contact | Wendy V Shotts |
| Correspondent | Wendy V Shotts ACT MEDICAL, INC. 150 CALIFORNIA ST. Newton, MA 02458 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-03 |
| Decision Date | 1999-05-14 |
| Summary: | summary |