The following data is part of a premarket notification filed by Hdc Maquinolas, Llc with the FDA for Maky 21.1 Dialyzer Reprocessing System.
| Device ID | K024076 |
| 510k Number | K024076 |
| Device Name: | MAKY 21.1 DIALYZER REPROCESSING SYSTEM |
| Classification | Dialyzer Reprocessing System |
| Applicant | HDC MAQUINOLAS, LLC 8508 BEACON BEND LN. Pearland, TX 77584 |
| Contact | Lori K Holder |
| Correspondent | Lori K Holder HDC MAQUINOLAS, LLC 8508 BEACON BEND LN. Pearland, TX 77584 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-10 |
| Decision Date | 2003-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00898021000037 | K024076 | 000 |