The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for K-shield Arterial Venous Fistula Set With Antineedle Stick Protector.
| Device ID | K102994 |
| 510k Number | K102994 |
| Device Name: | K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | KAWASUMI LABORATORIES, INC. 4723 OAK FAIR BLVD Tampa, FL 33610 |
| Contact | Jack Pavlo |
| Correspondent | Jack Pavlo KAWASUMI LABORATORIES, INC. 4723 OAK FAIR BLVD Tampa, FL 33610 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-08 |
| Decision Date | 2010-11-03 |
| Summary: | summary |