K133764 is an FDA 510(k) clearance for the CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL. This device is classified as a Dressing, Wound, Drug.
Submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on March 13, 2014, 92 days after receiving the submission on December 11, 2013.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K133764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2013 |
| Decision Date | March 13, 2014 |
| Days to Decision | 92 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |