The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Turkel Safety Pneumothorax Procedure Tray.
| Device ID | K934428 |
| 510k Number | K934428 |
| Device Name: | ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY |
| Classification | General Surgery Tray |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-10 |
| Decision Date | 1993-12-30 |