Titan SGS
Staple, Implantable
Standard Bariatrics
The following data is part of a premarket notification filed by Standard Bariatrics with the FDA for Titan Sgs.
Pre-market Notification Details
| Device ID | K210278 |
| 510k Number | K210278 |
| Device Name: | Titan SGS |
| Classification | Staple, Implantable |
| 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 | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-04-28 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851677007096 | K210278 | 000 |
| 00851677007089 | K210278 | 000 |
| 00851677007133 | K210278 | 000 |
| 00851677007164 | K210278 | 000 |
Trademark Results [Titan SGS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TITAN SGS 88114340 not registered Live/Pending |
STANDARD BARIATRICS, INC. 2018-09-12 |
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