The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for E-z-em Enteroclysis Catheter Set.
| Device ID | K911349 |
| 510k Number | K911349 |
| Device Name: | E-Z-EM ENTEROCLYSIS CATHETER SET |
| Classification | Catheter, Retention Type |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Merribeth Adams |
| Correspondent | Merribeth Adams E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | EZK |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-27 |
| Decision Date | 1992-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50815112021097 | K911349 | 000 |