The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Aspir-flex Suction Catheter.
Device ID | K925556 |
510k Number | K925556 |
Device Name: | ARGYLE ASPIR-FLEX SUCTION CATHETER |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Contact | Dennis Pozzo |
Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-03 |
Decision Date | 1993-07-30 |