The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Schneider Wallstent(r).
| Device ID | K911292 |
| 510k Number | K911292 |
| Device Name: | SCHNEIDER WALLSTENT(R) |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | PFIZER HOSPITAL PRODUCTS GROUP, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Steve Jwanouskos |
| Correspondent | Steve Jwanouskos PFIZER HOSPITAL PRODUCTS GROUP, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-25 |
| Decision Date | 1991-05-01 |