The following data is part of a premarket notification filed by Rti Surgical, Inc. with the FDA for Bovine Pericardium Suturable Dural Graft, Tutopatch Dm Graft, Tutoplast Bovine Pericardium Dm.
| Device ID | K132850 |
| 510k Number | K132850 |
| Device Name: | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM |
| Classification | Dura Substitute |
| Applicant | RTI SURGICAL, INC. 11621 Research Cir Alachua, FL 32615 |
| Contact | Esther Carbon |
| Correspondent | Esther Carbon RTI SURGICAL, INC. 11621 Research Cir Alachua, FL 32615 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-11 |
| Decision Date | 2014-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268BP112160 | K132850 | 000 |
| 10381780074229 | K132850 | 000 |
| 10381780074236 | K132850 | 000 |
| 10381780074243 | K132850 | 000 |
| 10381780074250 | K132850 | 000 |
| M268BP102070 | K132850 | 000 |
| M268BP104050 | K132850 | 000 |
| M268BP106080 | K132850 | 000 |
| M268BP108120 | K132850 | 000 |
| 10381780074212 | K132850 | 000 |