The following data is part of a premarket notification filed by H.w. Andersen Products, Inc. with the FDA for An3200 Doubilet Drain.
| Device ID | K872458 |
| 510k Number | K872458 |
| Device Name: | AN3200 DOUBILET DRAIN |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | H.W. ANDERSEN PRODUCTS, INC. 221 SOUTH ST. Oyster Bay, NY 11771 |
| Contact | Lauren R Andersen |
| Correspondent | Lauren R Andersen H.W. ANDERSEN PRODUCTS, INC. 221 SOUTH ST. Oyster Bay, NY 11771 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-23 |
| Decision Date | 1987-09-21 |