The following data is part of a premarket notification filed by Standard Bariatrics, Inc. with the FDA for Standard Tapered Bougie, 38 Fr..
| Device ID | K222085 |
| 510k Number | K222085 |
| Device Name: | Standard Tapered Bougie, 38 Fr. |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Standard Bariatrics, Inc. 4362 Glendale Milford Road Cincinnati, OH 45242 |
| Contact | Michelle Schnell |
| Correspondent | Michelle Schnell Standard Bariatrics, Inc. 4362 Glendale Milford Road Cincinnati, OH 45242 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-15 |
| Decision Date | 2022-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851677007123 | K222085 | 000 |
| 00851677007171 | K222085 | 000 |