The following data is part of a premarket notification filed by Solco Basle, Inc. with the FDA for Solcotrans Ortho. Drainage/reinfusion System.
| Device ID | K883058 |
| 510k Number | K883058 |
| Device Name: | SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | SOLCO BASLE, INC. 169 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Robert Cunningham |
| Correspondent | Robert Cunningham SOLCO BASLE, INC. 169 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-19 |
| Decision Date | 1988-10-28 |