The following data is part of a premarket notification filed by Carbon Medical Technologies, Inc. with the FDA for Endoscopic Injection Needle.
| Device ID | K172227 |
| 510k Number | K172227 |
| Device Name: | Endoscopic Injection Needle |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110 -5867 |
| Contact | Andrew J. Adams |
| Correspondent | Andrew J. Adams Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110 -5867 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-25 |
| Decision Date | 2017-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858015005940 | K172227 | 000 |