The following data is part of a premarket notification filed by Acro Biomedical Co., Ltd with the FDA for Abccolla Collagen Matrix.
| Device ID | K162348 |
| 510k Number | K162348 |
| Device Name: | ABCcolla Collagen Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | ACRO BIOMEDICAL CO., LTD 3F., NO.57, LUKE 2ND RD, LUJHU DIST. Kaohsiung City, TW 82151 |
| Contact | Dar-jen Hsieh |
| Correspondent | Dar-jen Hsieh ACRO BIOMEDICAL CO., LTD 3F., NO.57, LUKE 2ND RD, LUJHU DIST. Kaohsiung City, TW 82151 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-22 |
| Decision Date | 2017-05-10 |
| Summary: | summary |