The following data is part of a premarket notification filed by Solco Basle, Inc. with the FDA for Solcotrans Orthopaedic Drainage/reinfusion System.
| Device ID | K913177 |
| 510k Number | K913177 |
| Device Name: | SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | SOLCO BASLE, INC. 72 SHARP ST. HINGHAM CORPORATE CTR. Hingham, MA 02043 |
| Contact | Robert W Cunningham |
| Correspondent | Robert W Cunningham SOLCO BASLE, INC. 72 SHARP ST. HINGHAM CORPORATE CTR. Hingham, MA 02043 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-17 |
| Decision Date | 1993-02-25 |