The following data is part of a premarket notification filed by Aspire Bariatrics, Inc with the FDA for Aspire Venting Tube.
| Device ID | K182248 |
| 510k Number | K182248 |
| Device Name: | Aspire Venting Tube |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Aspire Bariatrics, Inc 3200 Horizon Dirve Suite 100 King Of Prussia, PA 19406 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante Aspire Bariatrics, Inc 3200 Horizon Dirve Suite 100 King Of Prussia, PA 19406 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-20 |
| Decision Date | 2018-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10857808005891 | K182248 | 000 |