The following data is part of a premarket notification filed by Entech, Inc. with the FDA for Gilsdorf Percu. Endo.-peg & Percu. Flouro.-pfg.
| Device ID | K891371 |
| 510k Number | K891371 |
| Device Name: | GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ENTECH, INC. ROUTE 22 EAST Lebanon, NJ 08833 |
| Contact | Laurence A Potter |
| Correspondent | Laurence A Potter ENTECH, INC. ROUTE 22 EAST Lebanon, NJ 08833 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-09 |
| Decision Date | 1989-08-03 |