The following data is part of a premarket notification filed by Corbin Clinical Resources, Llc with the FDA for Precision Point Biopsy Needle Guide.
| Device ID | K160414 |
| 510k Number | K160414 |
| Device Name: | Precision Point Biopsy Needle Guide |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Corbin Clinical Resources, LLC 12234 Williams Road Cumberland, MD 21502 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz Corbin Clinical Resources, LLC 12234 Williams Road Cumberland, MD 21502 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B371P1001 | K160414 | 000 |
| B371P10024 | K160414 | 000 |
| B371P10010 | K160414 | 000 |
| B371P10022 | K160414 | 000 |