The following data is part of a premarket notification filed by Biocer Entwicklungs Gmbh with the FDA for Tio2mesh Tm.
| Device ID | K113311 |
| 510k Number | K113311 |
| Device Name: | TIO2MESH TM |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | BIOCER ENTWICKLUNGS GMBH 611 WEST 5TH ST. THIRD FLOOR Austin, TX 78701 |
| Contact | Cheryl Fisher |
| Correspondent | Cheryl Fisher BIOCER ENTWICKLUNGS GMBH 611 WEST 5TH ST. THIRD FLOOR Austin, TX 78701 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-09 |
| Decision Date | 2012-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBCEMFP1310 | K113311 | 000 |
| EBCBMFP1020 | K113311 | 000 |
| EBCBMFP1030 | K113311 | 000 |
| EBCBMFP1050 | K113311 | 000 |
| EBCBMFP1100 | K113311 | 000 |
| EBCBMFP1110 | K113311 | 000 |
| EBCBMFP1120 | K113311 | 000 |
| EBCBMFP1210 | K113311 | 000 |
| EBCBMFP1320 | K113311 | 000 |
| EBCBMFP1330 | K113311 | 000 |
| EBCBMFP1410 | K113311 | 000 |
| EBCBMFP3010 | K113311 | 000 |
| EBCBMFP3320 | K113311 | 000 |
| EBCBMFP3330 | K113311 | 000 |
| EBCBMFP3410 | K113311 | 000 |
| EBCBMFP1010 | K113311 | 000 |