The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Salman Sinus Button.
| Device ID | K922902 |
| 510k Number | K922902 |
| Device Name: | SALMAN SINUS BUTTON |
| Classification | Cannula, Sinus |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
| Contact | Stuart K Montgomery |
| Correspondent | Stuart K Montgomery BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
| Product Code | KAM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-16 |
| Decision Date | 1993-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBESSS20000 | K922902 | 000 |
| 34063107102159 | K922902 | 000 |