The following data is part of a premarket notification filed by Hans Biomed Corporation with the FDA for Surfuse Gel, Surfuse Putty, Exfuse Gel, Exfuse Putty.
| Device ID | K171568 |
| 510k Number | K171568 |
| Device Name: | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Hans Biomed Corporation 64, Yuseong-daero 1628 Beon-gil Yuseong-gu Daejeon, KR 34054 |
| Contact | Lucy Choi |
| Correspondent | Patsy J. Trisler Trisler Consulting 5600 Wisconsin Avenue #509 Chevy Chase, MD 20815 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-05-30 |
| Decision Date | 2018-02-22 |
| Summary: | summary |