The following data is part of a premarket notification filed by Standard Bariatrics with the FDA for Disposable Standard Clamp.
| Device ID | K190788 |
| 510k Number | K190788 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-27 |
| Decision Date | 2019-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851677007027 | K190788 | 000 |