The following data is part of a premarket notification filed by Solco Basle, Inc. with the FDA for Solcotrans Chest Drainage Autotransfusion System.
Device ID | K872590 |
510k Number | K872590 |
Device Name: | SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM |
Classification | Apparatus, Autotransfusion |
Applicant | SOLCO BASLE, INC. 169 WEYMOUTH ST. Rockland, MA 02370 |
Contact | Rosanne Terraciano |
Correspondent | Rosanne Terraciano 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 | 1987-07-01 |
Decision Date | 1987-09-04 |