The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for E-z P.e.g. W/percutaneous Endoscopy Gastrostomy.
| Device ID | K852535 |
| 510k Number | K852535 |
| Device Name: | E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Contact | W. A Fry |
| Correspondent | W. A Fry TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-14 |
| Decision Date | 1985-10-17 |