The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Trocar Sleeve And Accessories, Models 1287-xx-xx.
| Device ID | K012771 |
| 510k Number | K012771 |
| Device Name: | TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PAJUNK GMBH AM HOLZPLATZ 5-7 Geisingen, DE D-78187 |
| Contact | Martin Hanger |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-08-17 |
| Decision Date | 2001-11-14 |
| Summary: | summary |