The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Turkel Safety Thoracentesis Proc. Tray.
Device ID | K930847 |
510k Number | K930847 |
Device Name: | ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY |
Classification | Syringe, Piston |
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 | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-18 |
Decision Date | 1993-07-12 |