The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Pajunk Disposable Balloons And Balloon Systems.
| Device ID | K090631 |
| 510k Number | K090631 |
| Device Name: | PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 01 Geisingen, Baden-wurttemberg, DE 78187 |
| Contact | Christian G Quass |
| Correspondent | Christian G Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 01 Geisingen, Baden-wurttemberg, DE 78187 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-09 |
| Decision Date | 2009-04-16 |
| Summary: | summary |