The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Epilong Kit For Anesthesiology.
| Device ID | K060311 |
| 510k Number | K060311 |
| Device Name: | EPILONG KIT FOR ANESTHESIOLOGY |
| Classification | Anesthesia Conduction Kit |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, Baden-wurttemberg, DE 78187 |
| Contact | Christian Quass |
| Correspondent | Christian Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, Baden-wurttemberg, DE 78187 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-08 |
| Decision Date | 2006-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223133156 | K060311 | 000 |
| 04048223129319 | K060311 | 000 |
| 04048223129401 | K060311 | 000 |
| 04048223129418 | K060311 | 000 |
| 04048223129425 | K060311 | 000 |
| 04048223129494 | K060311 | 000 |
| 04048223129500 | K060311 | 000 |
| 04048223129845 | K060311 | 000 |
| 04048223129852 | K060311 | 000 |
| 04048223129210 | K060311 | 000 |