The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Winged Collection Set W/multi-sample Luer Adapter.
| Device ID | K935505 |
| 510k Number | K935505 |
| Device Name: | WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | KAWASUMI LABORATORIES CO., LTD. 3-28-15 MINAMI OHI, SHINAGAWA- KU Tokyo, JP 140 |
| Contact | Shozo Moriyama |
| Correspondent | Shozo Moriyama KAWASUMI LABORATORIES CO., LTD. 3-28-15 MINAMI OHI, SHINAGAWA- KU Tokyo, JP 140 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-16 |
| Decision Date | 1994-02-03 |