The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Sentinel Seal Autotransfusion System.
| Device ID | K864374 |
| 510k Number | K864374 |
| Device Name: | ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Frank S Morrison |
| Correspondent | Frank S Morrison SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-05 |
| Decision Date | 1987-03-16 |