The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Silicone Central Venous Cath-.
Device ID | K843450 |
510k Number | K843450 |
Device Name: | ARGYLE SILICONE CENTRAL VENOUS CATH- |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
Contact | Frank J Fucile |
Correspondent | Frank J Fucile SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-05 |
Decision Date | 1984-11-15 |