The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Rutter Supra Stomal Stents.
| Device ID | K091135 |
| 510k Number | K091135 |
| Device Name: | RUTTER SUPRA STOMAL STENTS |
| Classification | Prosthesis, Larynx (stents And Keels) |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Contact | Michael A Warren |
| Correspondent | Michael A Warren BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Product Code | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES8400150 | K091135 | 000 |
| 14063107101721 | K091135 | 000 |
| 14063107101714 | K091135 | 000 |
| 14063107101707 | K091135 | 000 |
| 14063107101691 | K091135 | 000 |
| 14063107101684 | K091135 | 000 |
| 14063107101677 | K091135 | 000 |
| 14063107101660 | K091135 | 000 |
| 14063107101653 | K091135 | 000 |
| 14063107101738 | K091135 | 000 |
| EBES8400060 | K091135 | 000 |
| EBES8400140 | K091135 | 000 |
| EBES8400130 | K091135 | 000 |
| EBES8400120 | K091135 | 000 |
| EBES8400110 | K091135 | 000 |
| EBES8400100 | K091135 | 000 |
| EBES8400090 | K091135 | 000 |
| EBES8400080 | K091135 | 000 |
| EBES8400070 | K091135 | 000 |
| 14063107101646 | K091135 | 000 |