The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Turkel Safety Paracentesis Procedure Tray.
| Device ID | K935238 |
| 510k Number | K935238 |
| Device Name: | ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY |
| Classification | Wrap, Sterilization |
| 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 | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1994-02-17 |