The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Empower Transfer Set, (cat. No. 7725).
| Device ID | K041178 |
| 510k Number | K041178 |
| Device Name: | EMPOWER TRANSFER SET, (CAT. NO. 7725) |
| Classification | Tubing, Fluid Delivery |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Judy Hauser |
| Correspondent | Judy Hauser E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-05 |
| Decision Date | 2004-07-16 |
| Summary: | summary |