The following data is part of a premarket notification filed by Entrigue Surgical, Inc. with the FDA for Sinus Dilation System.
| Device ID | K121351 |
| 510k Number | K121351 |
| Device Name: | SINUS DILATION SYSTEM |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ENTRIGUE SURGICAL, INC. 12672 SILICON DR. STE 150 San Antonio, TX 78249 |
| Contact | Gabriele G Niederauer, Ph.d. |
| Correspondent | Gabriele G Niederauer, Ph.d. ENTRIGUE SURGICAL, INC. 12672 SILICON DR. STE 150 San Antonio, TX 78249 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-04 |
| Decision Date | 2012-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470009729 | K121351 | 000 |
| 00817470009521 | K121351 | 000 |