The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Surshield Safety Winged Infusion Set.
| Device ID | K031266 |
| 510k Number | K031266 |
| Device Name: | SURSHIELD SAFETY WINGED INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Barbara Smith |
| Correspondent | Barbara Smith TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-21 |
| Decision Date | 2003-05-30 |
| Summary: | summary |