The following data is part of a premarket notification filed by Kawasumi Laboratories America, Inc. with the FDA for K-shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and Multisample Luer Adapter).
| Device ID | K102890 |
| 510k Number | K102890 |
| Device Name: | K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) |
| Classification | Set, Administration, Intravascular |
| Applicant | KAWASUMI LABORATORIES AMERICA, INC. 4723 OAK FAIR BLVD. Tampa, FL 33610 |
| Contact | Jack Pavlo |
| Correspondent | Jack Pavlo KAWASUMI LABORATORIES AMERICA, INC. 4723 OAK FAIR BLVD. Tampa, FL 33610 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2010-10-21 |
| Summary: | summary |