The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Modular Valve Handles For Adaptable Tubes, Model 1298-xx-xx, 1295-xx-xx.
| Device ID | K011997 |
| 510k Number | K011997 |
| Device Name: | MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PAJUNK GMBH AM HOLZPLATZ 5-7 Geisingen, DE D-78187 |
| Contact | Martin Hauger |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-06-27 |
| Decision Date | 2001-07-10 |
| Summary: | summary |