The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Slim Line Retention Tip W/ Silicone Rubber Cuff.
| Device ID | K905574 |
| 510k Number | K905574 |
| Device Name: | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF |
| Classification | Catheter, Retention, Barium Enema With Bag |
| Applicant | E-Z-EM, INC. 373 PLANTATION ST. Worcester, MA 01605 |
| Contact | Georganne Brown |
| Correspondent | Georganne Brown E-Z-EM, INC. 373 PLANTATION ST. Worcester, MA 01605 |
| Product Code | FGD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-12 |
| Decision Date | 1991-01-24 |