The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for E-z Peg.
| Device ID | K921680 |
| 510k Number | K921680 |
| Device Name: | E-Z PEG |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Contact | Mark Heller |
| Correspondent | Mark Heller MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1994-05-06 |