The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Wallflex Enteral Duodenal Stent With Anchor Lock Delivery System, Models M00565010, M00565020, M00565030.
| Device ID | K062750 |
| 510k Number | K062750 |
| Device Name: | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 |
| Classification | Stent, Metallic, Expandable, Duodenal |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Allyson Barford |
| Correspondent | Allyson Barford BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | MUM |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-14 |
| Decision Date | 2006-12-04 |
| Summary: | summary |