The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Sonolong Sono, Curl Sono, Nanoline, Brand Names Carryingsono/sonolong.
| Device ID | K113188 |
| 510k Number | K113188 |
| Device Name: | SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG |
| Classification | Anesthesia Conduction Kit |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, DE 78187 |
| Contact | Christian G Quass |
| Correspondent | Christian G Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, DE 78187 |
| Product Code | CAZ |
| Subsequent Product Code | BSO |
| Subsequent Product Code | BSP |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223128831 | K113188 | 000 |
| 04048223128589 | K113188 | 000 |
| 04048223128565 | K113188 | 000 |
| 04048223128558 | K113188 | 000 |
| 04048223128527 | K113188 | 000 |
| 04048223128435 | K113188 | 000 |
| 04048223128404 | K113188 | 000 |
| 04048223128398 | K113188 | 000 |
| 04048223128312 | K113188 | 000 |
| 04048223128206 | K113188 | 000 |
| 04048223128596 | K113188 | 000 |
| 04048223128602 | K113188 | 000 |
| 04048223128800 | K113188 | 000 |
| 04048223128763 | K113188 | 000 |
| 04048223128756 | K113188 | 000 |
| 04048223128701 | K113188 | 000 |
| 04048223128688 | K113188 | 000 |
| 04048223128664 | K113188 | 000 |
| 04048223128640 | K113188 | 000 |
| 04048223128633 | K113188 | 000 |
| 04048223128626 | K113188 | 000 |
| 04048223128190 | K113188 | 000 |