K945313 is an FDA 510(k) clearance for the SPARTA HYDROGEL WOUND DRESSING. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Sparta Surgical Corp. (Hammonton, US). The FDA issued a Cleared decision on January 12, 1995, 72 days after receiving the submission on November 1, 1994.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K945313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1994 |
| Decision Date | January 12, 1995 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |