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 |