The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ultraflex Precision Colonic Stent, Models M00557330, Mo00557360, M00557380.
| Device ID | K060323 |
| 510k Number | K060323 |
| Device Name: | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Jennifer Kimball |
| Correspondent | Jennifer Kimball Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-09 |
| Decision Date | 2006-05-12 |
| Summary: | summary |