The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Stimulong Plus Catheter Set Model, Various.
Device ID | K033018 |
510k Number | K033018 |
Device Name: | STIMULONG PLUS CATHETER SET MODEL, VARIOUS |
Classification | Anesthesia Conduction Kit |
Applicant | PAJUNK GMBH 5010 NW CRESCENT VALLEY DR. Corvallis, OR 97330 |
Contact | Burk A Brandt |
Correspondent | Burk A Brandt PAJUNK GMBH 5010 NW CRESCENT VALLEY DR. Corvallis, OR 97330 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-26 |
Decision Date | 2004-05-05 |
Summary: | summary |