The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Colorado Microdissection Needle.
Device ID | K033232 |
510k Number | K033232 |
Device Name: | COLORADO MICRODISSECTION NEEDLE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | STRYKER CORP. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 -6197 |
Contact | Wade T Rutkoskie |
Correspondent | Wade T Rutkoskie STRYKER CORP. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 -6197 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-06 |
Decision Date | 2004-02-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COLORADO MICRODISSECTION NEEDLE 74353627 1817843 Dead/Cancelled |
Colorado Biomedical, Inc. 1993-01-29 |