The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Colorado Microdissection Needle.
| Device ID | K000348 |
| 510k Number | K000348 |
| Device Name: | COLORADO MICRODISSECTION NEEDLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Kristyn R Kelley |
| Correspondent | Kristyn R Kelley STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-03 |
| Decision Date | 2000-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COLORADO MICRODISSECTION NEEDLE 74353627 1817843 Dead/Cancelled |
Colorado Biomedical, Inc. 1993-01-29 |