The following data is part of a premarket notification filed by Standard Bariatrics with the FDA for Disposable Standard Clamp.
| Device ID | K170379 |
| 510k Number | K170379 |
| Device Name: | Disposable Standard Clamp |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati, OH 45242 |
| Contact | Alison Sathe |
| Correspondent | Alison Sathe Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati, OH 45242 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-07 |
| Decision Date | 2017-07-19 |
| Summary: | summary |