The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Pajunk Modular Handle Instruments.
| Device ID | K033249 |
| 510k Number | K033249 |
| Device Name: | PAJUNK MODULAR HANDLE INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PAJUNK GMBH 203 MAIN STREET, PMB 166 Flemington,, NJ 08822 |
| Contact | Lynette L Howard |
| Correspondent | Lynette L Howard PAJUNK GMBH 203 MAIN STREET, PMB 166 Flemington,, NJ 08822 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-07 |
| Decision Date | 2004-03-05 |
| Summary: | summary |