The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Ercp Contrast Delivery Set.
| Device ID | K915813 |
| 510k Number | K915813 |
| Device Name: | ACKRAD ERCP CONTRAST DELIVERY SET |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman |
| Correspondent | Bernard Ackerman ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1992-03-11 |