K901368 is an FDA 510(k) clearance for the HEMOSPAL KITS A1, A2D, AO, & A1D. This device is classified as a Dialyzer, Parallel Flow (Class II - Special Controls, product code FJG).
Submitted by Gambro-Hospal, Inc. (Williamsburg, US). The FDA issued a Cleared decision on August 2, 1990, 132 days after receiving the submission on March 23, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K901368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1990 |
| Decision Date | August 02, 1990 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FJG — Dialyzer, Parallel Flow |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |