The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Optimized Positioning System (ops) Plan.
| Device ID | K183038 |
| 510k Number | K183038 |
| Device Name: | Corin Optimized Positioning System (OPS) Plan |
| Classification | System, Image Processing, Radiological |
| Applicant | Corin USA 12750 Citrus Park Lane, Suite 120 Tampa, FL 33625 |
| Contact | Lucinda Gerber |
| Correspondent | Martina Cecconi Corin (Australia) 17 Bridge Street Pymble, AU 2073 |
| Product Code | LLZ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-01 |
| Decision Date | 2018-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351327000091 | K183038 | 000 |