The following data is part of a premarket notification filed by Biomedical Enterprises, Inc with the FDA for Speed Shift.
Device ID | K124022 |
510k Number | K124022 |
Device Name: | SPEED SHIFT |
Classification | Staple, Fixation, Bone |
Applicant | BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 San Antonio, TX 78245 |
Contact | Joe Soward |
Correspondent | Joe Soward BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 San Antonio, TX 78245 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-28 |
Decision Date | 2013-05-14 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SPEED SHIFT 98641244 not registered Live/Pending |
Lubrication Specialties, LLC 2024-07-10 |
![]() SPEED SHIFT 85427472 4160437 Live/Registered |
Reliable Diamond Tool, Inc. 2011-09-20 |
![]() SPEED SHIFT 76361484 2801780 Live/Registered |
Lifetime Products, Inc. 2002-01-22 |
![]() SPEED SHIFT 75425830 not registered Dead/Abandoned |
Lifetime Products, Inc. 1998-01-29 |
![]() SPEED SHIFT 75420200 2498603 Live/Registered |
INTIME SOLUTIONS INC. 1998-01-20 |
![]() SPEED SHIFT 74489800 not registered Dead/Abandoned |
Coastal Unilube, Inc. 1994-02-14 |