The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Modification To: Plexalong Sets.
| Device ID | K042979 |
| 510k Number | K042979 |
| Device Name: | MODIFICATION TO: PLEXALONG SETS |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| 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 | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-29 |
| Decision Date | 2004-12-21 |
| Summary: | summary |