The following data is part of a premarket notification filed by Dalim Surgnet Corporation with the FDA for Octotmport.
| Device ID | K112196 |
| 510k Number | K112196 |
| Device Name: | OCTOTMPORT |
| Classification | Laparoscopic Single Port Access Device |
| Applicant | DALIM SURGNET CORPORATION 325 N PUENTE ST. UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee DALIM SURGNET CORPORATION 325 N PUENTE ST. UNIT B Brea, CA 92821 |
| Product Code | OTJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-01 |
| Decision Date | 2011-09-14 |
| Summary: | summary |