The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Atraumatic Standard Sprotte Needle.
| Device ID | K911260 |
| 510k Number | K911260 |
| 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 F Mackler |
| Correspondent | Bruce F 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 | 1991-03-22 |
| Decision Date | 1991-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902114147 | K911260 | 000 |
| 20801902201991 | K911260 | 000 |
| 20801902202011 | K911260 | 000 |
| 20801902202035 | K911260 | 000 |
| 20801902168010 | K911260 | 000 |
| 20801902064077 | K911260 | 000 |
| 20801902074250 | K911260 | 000 |
| 10801902074222 | K911260 | 000 |
| 50801902074176 | K911260 | 000 |
| 20801902201984 | K911260 | 000 |
| 20801902202028 | K911260 | 000 |
| 20801902202189 | K911260 | 000 |
| 20801902114161 | K911260 | 000 |
| 20801902114185 | K911260 | 000 |
| 20801902114192 | K911260 | 000 |
| 20801902191803 | K911260 | 000 |
| 20801902191810 | K911260 | 000 |
| 20801902202271 | K911260 | 000 |
| 20801902202288 | K911260 | 000 |
| 20801902202004 | K911260 | 000 |
| 50801902074183 | K911260 | 000 |
| 50801902074206 | K911260 | 000 |
| 50801902074268 | K911260 | 000 |
| 40801902126243 | K911260 | 000 |
| 40801902126267 | K911260 | 000 |
| 40801902126274 | K911260 | 000 |
| 20801902126157 | K911260 | 000 |
| 20801902126218 | K911260 | 000 |
| 20801902126249 | K911260 | 000 |
| 30801902059964 | K911260 | 000 |
| 30801902076923 | K911260 | 000 |
| 40801902126229 | K911260 | 000 |
| 40801902126212 | K911260 | 000 |
| 40801902126199 | K911260 | 000 |
| 40801902074193 | K911260 | 000 |
| 20801902162728 | K911260 | 000 |
| 20801902162742 | K911260 | 000 |
| 20801902158868 | K911260 | 000 |
| 20801902059967 | K911260 | 000 |
| 40801902126151 | K911260 | 000 |
| 40801902126168 | K911260 | 000 |
| 40801902126182 | K911260 | 000 |
| 30801902076930 | K911260 | 000 |