The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Gastrointestinal Tube.
| Device ID | K851671 |
| 510k Number | K851671 |
| Device Name: | GASTROINTESTINAL TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Contact | John A Steen |
| Correspondent | John A Steen SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-06-14 |