The following data is part of a premarket notification filed by Medical Solutions International with the FDA for Bipro Model Sds-cb200.
| Device ID | K033118 |
| 510k Number | K033118 |
| Device Name: | BIPRO MODEL SDS-CB200 |
| Classification | Tank, Holding, Dialysis |
| Applicant | MEDICAL SOLUTIONS INTERNATIONAL 11522 W 90TH ST. Overland Park, KS 66214 |
| Contact | Jack Dillon |
| Correspondent | Jack Dillon MEDICAL SOLUTIONS INTERNATIONAL 11522 W 90TH ST. Overland Park, KS 66214 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B285SDSCB2001 | K033118 | 000 |