The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Modification To Pajunk Stimulong Plus Catheter Sets.
Device ID | K043130 |
510k Number | K043130 |
Device Name: | MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS |
Classification | Anesthesia Conduction Kit |
Applicant | PAJUNK GMBH 5101 NW CRESCENT VALLEY DR. Corvallis, OR 97330 |
Contact | Burk A Brandt |
Correspondent | Burk A Brandt PAJUNK GMBH 5101 NW CRESCENT VALLEY DR. Corvallis, OR 97330 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-12 |
Decision Date | 2004-12-21 |
Summary: | summary |