The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Atraumatic Standard Sprotte Needle.
| Device ID | K911202 |
| 510k Number | K911202 |
| Device Name: | ATRAUMATIC STANDARD SPROTTE NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | PAJUNK GMBH WASHINGTON SQUARE SUITE 1100 1050 CONNECTICUT AVENUE N.W. Washington, DC 20036 |
| Contact | Bruce Mackler |
| Correspondent | Bruce Mackler PAJUNK GMBH WASHINGTON SQUARE SUITE 1100 1050 CONNECTICUT AVENUE N.W. Washington, DC 20036 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-19 |
| Decision Date | 1992-05-04 |