The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Salem Sump Tube Anti-reflux Valve Insertion Tray.
| Device ID | K935781 |
| 510k Number | K935781 |
| Device Name: | ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY |
| Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | FEG |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-06 |
| Decision Date | 1995-01-27 |