The following data is part of a premarket notification filed by Sts Medical with the FDA for Composite Removable Sinus Stent System.
| Device ID | K170913 |
| 510k Number | K170913 |
| Device Name: | Composite Removable Sinus Stent System |
| Classification | Splint, Intranasal Septal |
| Applicant | STS Medical 37 Amal Petah Tikva, IL 4951337 |
| Contact | Lena Shlossberg |
| Correspondent | George J. Hattub Medicsense 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-28 |
| Decision Date | 2017-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290019367000 | K170913 | 000 |