The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for Winged Needle Sets With An Antineedle Stick Protector.
| Device ID | K023917 |
| 510k Number | K023917 |
| Device Name: | WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | KAWASUMI LABORATORIES, INC. 1800 MASSACHUSETTS AVE. N.W. SUITE 200 Washington, DC 20036 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone KAWASUMI LABORATORIES, INC. 1800 MASSACHUSETTS AVE. N.W. SUITE 200 Washington, DC 20036 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-25 |
| Decision Date | 2003-02-26 |
| Summary: | summary |