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 |