The following data is part of a premarket notification filed by Standard Bariatrics with the FDA for Standard Bougie, 38 Fr. And Hand Pump.
| Device ID | K212728 |
| 510k Number | K212728 |
| Device Name: | Standard Bougie, 38 Fr. And Hand Pump |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati, OH 45242 |
| Contact | Michelle Schnell |
| Correspondent | Michelle Schnell Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati, OH 45242 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-27 |
| Decision Date | 2021-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851677007116 | K212728 | 000 |