The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Cholangiography Set.
| Device ID | K943435 |
| 510k Number | K943435 |
| Device Name: | CHOLANGIOGRAPHY SET |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-18 |
| Decision Date | 1994-11-07 |