The following data is part of a premarket notification filed by Carbon Medical Technologies, Inc. with the FDA for Carbon Medical Technologies Endoscopic Injection Needle.
| Device ID | K042615 |
| 510k Number | K042615 |
| Device Name: | CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Robert W Johnson |
| Correspondent | Robert W Johnson CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-24 |
| Decision Date | 2004-11-05 |
| Summary: | summary |