The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Sono Tap, Tuohy Sono.
| Device ID | K113207 |
| 510k Number | K113207 |
| Device Name: | SONO TAP, TUOHY SONO |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | PAJUNK GMBH KARL-HALL-STRASSE 1 Geisingen, DE D-78187 |
| Contact | Christian Quass |
| Correspondent | Christian Quass PAJUNK GMBH KARL-HALL-STRASSE 1 Geisingen, DE D-78187 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-02-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223131541 | K113207 | 000 |
| 04048223019788 | K113207 | 000 |
| 04048223019771 | K113207 | 000 |
| 04048223019764 | K113207 | 000 |
| 04048223021217 | K113207 | 000 |
| 04048223057964 | K113207 | 000 |
| 04048223056158 | K113207 | 000 |
| 04048223056141 | K113207 | 000 |
| 04048223078532 | K113207 | 000 |
| 04048223033289 | K113207 | 000 |
| 04048223033227 | K113207 | 000 |
| 04048223033210 | K113207 | 000 |
| 04048223033203 | K113207 | 000 |
| 04048223033838 | K113207 | 000 |
| 04048223033821 | K113207 | 000 |
| 04048223113127 | K113207 | 000 |
| 04048223113424 | K113207 | 000 |
| 04048223113431 | K113207 | 000 |
| 04048223129753 | K113207 | 000 |
| 04048223129586 | K113207 | 000 |
| 04048223129487 | K113207 | 000 |
| 04048223129470 | K113207 | 000 |
| 04048223129449 | K113207 | 000 |
| 04048223129371 | K113207 | 000 |
| 04048223128732 | K113207 | 000 |
| 04048223128442 | K113207 | 000 |
| 04048223128183 | K113207 | 000 |
| 04048223113486 | K113207 | 000 |
| 04048223113479 | K113207 | 000 |
| 04048223113462 | K113207 | 000 |
| 04048223113455 | K113207 | 000 |
| 04048223113448 | K113207 | 000 |
| 04048223021514 | K113207 | 000 |