The following data is part of a premarket notification filed by Navotek Medical Ltd with the FDA for Tracer Implantation Kit, Index Implantation Kit.
| Device ID | K110971 |
| 510k Number | K110971 |
| Device Name: | TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT |
| Classification | Accelerator, Linear, Medical |
| Applicant | NAVOTEK MEDICAL LTD 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Steven B Datlof |
| Correspondent | Steven B Datlof NAVOTEK MEDICAL LTD 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-06 |
| Decision Date | 2012-01-10 |
| Summary: | summary |