The following data is part of a premarket notification filed by Entrigue Surgical, Inc. with the FDA for Entact Septal Stapler, Model 610-00100.
| Device ID | K082750 |
| 510k Number | K082750 |
| Device Name: | ENTACT SEPTAL STAPLER, MODEL 610-00100 |
| Classification | Septal Stapler/absorbable Staples |
| Applicant | ENTRIGUE SURGICAL, INC. 12672 SILICON DRIVE SUITE 150 San Antonio, TX 78249 |
| Contact | Gabriele G Niederauer |
| Correspondent | Gabriele G Niederauer ENTRIGUE SURGICAL, INC. 12672 SILICON DRIVE SUITE 150 San Antonio, TX 78249 |
| Product Code | OLL |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-19 |
| Decision Date | 2009-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470006469 | K082750 | 000 |
| 20817470006456 | K082750 | 000 |