The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Enterocysis Tube W/guide Wire & Connect.
| Device ID | K840752 |
| 510k Number | K840752 |
| Device Name: | ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | E-Z-EM, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-05-02 |