The following data is part of a premarket notification filed by Remicalm, Llc with the FDA for Trimira Ocs 3000.
| Device ID | K082603 |
| 510k Number | K082603 |
| Device Name: | TRIMIRA OCS 3000 |
| Classification | Diagnostic Light, Soft Tissue Detector |
| Applicant | REMICALM, LLC 952 ECHO LANE, SUITE 333 Houston, TX 77024 -2758 |
| Contact | David B Jones |
| Correspondent | David B Jones REMICALM, LLC 952 ECHO LANE, SUITE 333 Houston, TX 77024 -2758 |
| Product Code | NXV |
| CFR Regulation Number | 872.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2008-12-12 |
| Summary: | summary |