The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles.
| Device ID | K040965 |
| 510k Number | K040965 |
| Device Name: | PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | PAJUNK GMBH 203 MAIN STREET, PMB 166 Flemington,, NJ 08822 |
| Contact | Lynette Howard |
| Correspondent | Lynette Howard PAJUNK GMBH 203 MAIN STREET, PMB 166 Flemington,, NJ 08822 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-14 |
| Decision Date | 2004-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223133316 | K040965 | 000 |
| 04048223003862 | K040965 | 000 |
| 04048223112762 | K040965 | 000 |
| 04048223112908 | K040965 | 000 |
| 04048223129036 | K040965 | 000 |
| 04048223129135 | K040965 | 000 |
| 04048223129173 | K040965 | 000 |
| 04048223129227 | K040965 | 000 |
| 04048223129296 | K040965 | 000 |
| 04048223131770 | K040965 | 000 |
| 04048223131800 | K040965 | 000 |
| 04048223003725 | K040965 | 000 |