The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Turkel Neonatal/pediatric Thoracic Catheter Insertion Tray And Thoracic Catheter System.
| Device ID | K960574 |
| 510k Number | K960574 |
| Device Name: | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM |
| Classification | Pneumoperitoneum Needle |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Product Code | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-12 |
| Decision Date | 1996-08-05 |
| Summary: | summary |