The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Argyle Aqua-seal All Purpose Autotransfusion Chest Drainage Unit And Optional Argyle Aqua-seal Evacuating Autotransfusio.
| Device ID | K970857 |
| 510k Number | K970857 |
| Device Name: | ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO |
| Classification | Apparatus, Autotransfusion |
| Applicant | DAVIS & GECK, INC. 1915 OLIVE ST. St. Louis, MO 63103 |
| Contact | Vanada Johnson |
| Correspondent | Vanada Johnson DAVIS & GECK, INC. 1915 OLIVE ST. St. Louis, MO 63103 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-10 |
| Decision Date | 1997-11-05 |
| Summary: | summary |