The following data is part of a premarket notification filed by Ibi Israel Biomedical Innovations Ltd. with the FDA for Endofast Reliant Scp, Endofast Reliant Lap.
| Device ID | K130059 |
| 510k Number | K130059 |
| Device Name: | ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP |
| Classification | Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Applicant | IBI ISRAEL BIOMEDICAL INNOVATIONS LTD. 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Contact | Elissa Burg |
| Correspondent | Elissa Burg IBI ISRAEL BIOMEDICAL INNOVATIONS LTD. 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Product Code | PBQ |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-10 |
| Decision Date | 2013-07-29 |
| Summary: | summary |