The following data is part of a premarket notification filed by Coreleader Biotech Co., Ltd. with the FDA for Hemo-bandage.
| Device ID | K151204 |
| 510k Number | K151204 |
| Device Name: | HEMO-Bandage |
| Classification | Dressing, Wound, Drug |
| Applicant | CORELEADER BIOTECH CO., LTD. 19F BUILD B, NO. 100, SEC 1 XINTAI 5TH RD, XIZHI DIST. New Taipei City, TW 22102 |
| Contact | Ya-wen Kuo |
| Correspondent | Ya-wen Kuo CORELEADER BIOTECH CO., LTD. 19F BUILD B, NO. 100, SEC 1 XINTAI 5TH RD, XIZHI DIST. New Taipei City, TW 22102 |
| 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 | 2015-05-05 |
| Decision Date | 2015-07-31 |
| Summary: | summary |