The following data is part of a premarket notification filed by Acro Biomedical Co., Ltd. with the FDA for Abccolla Bone Matrix.
| Device ID | K212156 |
| 510k Number | K212156 |
| Device Name: | ABCcolla Bone Matrix |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ACRO Biomedical Co., Ltd. 3rd Fl., No.57, Luke 2nd Rd., Lujhu Dist. Kaohsiung, TW 82151 |
| Contact | Dar-jen Hsieh |
| Correspondent | Dar-jen Hsieh ACRO Biomedical Co., Ltd. 3rd Fl., No.57, Luke 2nd Rd., Lujhu Dist. Kaohsiung, TW 82151 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2021-10-08 |