The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Corin Optimized Positioning System (ops™) Plan.
| Device ID | K171847 |
| 510k Number | K171847 |
| Device Name: | Corin Optimized Positioning System (OPS™) Plan |
| Classification | System, Image Processing, Radiological |
| Applicant | Corin USA Limited 12750 Citrus Park Lane, Suite 120 Tampa, FL 33625 |
| Contact | Kathy Trier |
| Correspondent | Martina Cecconi Corin USA Limited 12750 Citrus Park Lane, Suite 120 Tampa, FL 33625 |
| 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 | 2017-06-21 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351327000077 | K171847 | 000 |