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 |