The following data is part of a premarket notification filed by Hans Biomed Corp. with the FDA for Surfuse Gel And Putty, Exfuse Gel And Putty.
| Device ID | K113728 |
| 510k Number | K113728 |
| Device Name: | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | HANS BIOMED CORP. 5600 WISCONSIN AVENUE #509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler HANS BIOMED CORP. 5600 WISCONSIN AVENUE #509 Chevy Chase, MD 20815 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2012-11-15 |
| Summary: | summary |