The following data is part of a premarket notification filed by Solco Basle, Inc. with the FDA for Solco Basle Intraoperative Autottrnsfus.
| Device ID | K843821 |
| 510k Number | K843821 |
| Device Name: | SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS |
| Classification | Apparatus, Autotransfusion |
| Applicant | SOLCO BASLE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-28 |
| Decision Date | 1985-10-01 |