The following data is part of a premarket notification filed by Foshan United Medical Technologies Ltd. with the FDA for Ka01 Chitosan Wound Dressing.
| Device ID | K143124 |
| 510k Number | K143124 |
| Device Name: | KA01 Chitosan Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | FOSHAN UNITED MEDICAL TECHNOLOGIES LTD. 89 TAOYUAN EAST ROAD Shishan, Nanhai, Foshan, CN 528225 |
| Contact | John Cen |
| Correspondent | Marcia Palma NAMSA 4050 OLSON MEMORIAL HIGHWAY, SUITE 450 Minneapolis, MN 55422 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-31 |
| Decision Date | 2015-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06931132224092 | K143124 | 000 |
| 06931132224061 | K143124 | 000 |
| 06931132224030 | K143124 | 000 |
| 06931132224009 | K143124 | 000 |