The following data is part of a premarket notification filed by Giltech Plus, Inc. with the FDA for Giltech Plus Connecting Tube Set.
| Device ID | K983624 |
| 510k Number | K983624 |
| Device Name: | GILTECH PLUS CONNECTING TUBE SET |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | GILTECH PLUS, INC. P.O. BOX 728 Milford, PA 18337 |
| Contact | William J Giliam |
| Correspondent | William J Giliam GILTECH PLUS, INC. P.O. BOX 728 Milford, PA 18337 |
| Product Code | KDH |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-15 |
| Decision Date | 1999-03-18 |