The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Celiac Plexus Neurolysis Needle.
Device ID | K030618 |
510k Number | K030618 |
Device Name: | WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
Contact | Margaret J Posner |
Correspondent | Margaret J Posner WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-26 |
Decision Date | 2003-05-27 |
Summary: | summary |