The following data is part of a premarket notification filed by Hans Biomed Corp. with the FDA for Surfuse Ii Gel, Surfuse Ii Putty, Exfuse Ii Gel, Exfuse Ii Putty.
| Device ID | K130235 |
| 510k Number | K130235 |
| Device Name: | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY |
| Classification | Bone Grafting Material, Human Source |
| Applicant | HANS BIOMED CORP. 5600 WISCONSIN AVENUE #509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler, Jd, Rac |
| Correspondent | Patsy J Trisler, Jd, Rac HANS BIOMED CORP. 5600 WISCONSIN AVENUE #509 Chevy Chase, MD 20815 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-30 |
| Decision Date | 2014-01-10 |
| Summary: | summary |