The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Winged Infusion Set.
| Device ID | K885264 |
| 510k Number | K885264 |
| Device Name: | WINGED INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Jack T Berger |
| Correspondent | Jack T Berger E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-22 |
| Decision Date | 1989-01-31 |