The following data is part of a premarket notification filed by Solco Basle, Inc. with the FDA for Solcosept(tm) Blood Transfusion Filter.
| Device ID | K896203 |
| 510k Number | K896203 |
| Device Name: | SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER |
| Classification | Microfilter, Blood Transfusion |
| Applicant | SOLCO BASLE, INC. 72 SHARP ST. HINGHAM CORPORATE CTR. Hingham, MA 02043 |
| Contact | W Cunningham |
| Correspondent | W Cunningham SOLCO BASLE, INC. 72 SHARP ST. HINGHAM CORPORATE CTR. Hingham, MA 02043 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-26 |
| Decision Date | 1990-02-01 |