The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Aspr-care Closed Suction System.
| Device ID | K955831 |
| 510k Number | K955831 |
| Device Name: | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Contact | Frank Fucile |
| Correspondent | Frank Fucile SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1642 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-03-28 |
| Summary: | summary |