The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Epispin, Epispin Ii Safety, Epispin Ii, Epispin I, Epispin Iv.
| Device ID | K060563 |
| 510k Number | K060563 |
| Device Name: | EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV |
| Classification | Anesthesia Conduction Kit |
| Applicant | PAJUNK GMBH KARL-HALL-STRASSE 1 Geisingen, DE D-78187 |
| Contact | Christain Quass |
| Correspondent | Christain Quass PAJUNK GMBH KARL-HALL-STRASSE 1 Geisingen, DE D-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 | 2006-06-02 |
| Summary: | summary |