The following data is part of a premarket notification filed by Standard Bariatrics with the FDA for Standard Clamp.
| Device ID | K153358 |
| 510k Number | K153358 |
| Device Name: | Standard Clamp |
| Classification | Clamp, Surgical, 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 | GDJ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-20 |
| Decision Date | 2016-05-02 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STANDARD CLAMP 87530403 5500884 Live/Registered |
STANDARD BARIATRICS, INC. 2017-07-17 |