The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Dobbhoff Biliary Stent Set.
| Device ID | K901582 |
| 510k Number | K901582 |
| Device Name: | DOBBHOFF BILIARY STENT SET |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Contact | Peter Waeger |
| Correspondent | Peter Waeger BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-04 |
| Decision Date | 1990-06-22 |