The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Turkel Safety Trocar Thoracic Catheter.
Device ID | K933510 |
510k Number | K933510 |
Device Name: | ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER |
Classification | Catheter, Peritoneal |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Contact | K. Michael Kroehnke |
Correspondent | K. Michael Kroehnke SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Product Code | GBW |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-20 |
Decision Date | 1994-02-24 |